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2021-12-24

$Tesla Motors(TSLA)$ arggh regret not adding more when it was 900 ish but well

2021-12-14

$Tesla Motors(TSLA)$ tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.

2021-12-02

Surprised the price dropped so low. Tot it would stay around the offer px

Razer will be privatized at a price of HK $2.82 per share

2021-12-02

Yay tesla

Cathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks

2021-11-29

$Novavax(NVAX)$let's go. Will go up with the cases increasing

2021-11-16

$Razer(01337)$ ehat is happening! Woah

2021-11-15

$Tiger Brokers(TIGR)$cmon cmon let's go up like a helicopter

2021-10-23

$Digital World Acquisition Corp(DWAC)$ anyone considering keeping till next week?

2021-10-20

Sigh

Novavax plunged over 20% in premarket trading

2021-10-20

Sigh

Novavax plunged over 20% in premarket trading

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href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;arggh regret not adding more when it was 900 ish but well","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;arggh regret not adding more when it was 900 ish but well","text":"$Tesla Motors(TSLA)$ arggh regret not adding more when it was 900 ish but well","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/698921927","isVote":1,"tweetType":1,"viewCount":940,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":607985689,"gmtCreate":1639474734030,"gmtModify":1639474734131,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.&nbsp;","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.&nbsp;","text":"$Tesla Motors(TSLA)$ tsla has been panned over the years but if you look at the price movement over the years it's always recovered. 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Tot it would stay around the offer px","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603265914","repostId":"1197247033","repostType":2,"repost":{"id":"1197247033","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1638406745,"share":"https://www.laohu8.com/m/news/1197247033?lang=&edition=full","pubTime":"2021-12-02 08:59","market":"hk","language":"en","title":"Razer will be privatized at a price of HK $2.82 per share","url":"https://stock-news.laohu8.com/highlight/detail?id=1197247033","media":"Tiger Newspress","summary":"A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10","content":"<p>A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10.79 billion Hong Kong dollars (US$1.38 billion) to take the Hong Kong-listed company private.</p>\n<p>Private-equity firm CVC Capital Partners is part of the consortium, Razer said Thursday in a filing to the Hong Kong bourse.</p>\n<p>The consortium is offering HK$2.82 a share to buy all shares it doesn't currently hold, representing a 5.6% premium to the stock's last closing price. The offer is final, Razer said.</p>\n<p>Razer, which sells gear for gamers such as keyboards and headphones and has bases in California and Singapore, was founded in 2005 and went public in 2017. Shares are up 12% this year, but remain well below their initial public offering price.</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Razer will be privatized at a price of HK $2.82 per share</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nRazer will be privatized at a price of HK $2.82 per share\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-12-02 08:59</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10.79 billion Hong Kong dollars (US$1.38 billion) to take the Hong Kong-listed company private.</p>\n<p>Private-equity firm CVC Capital Partners is part of the consortium, Razer said Thursday in a filing to the Hong Kong bourse.</p>\n<p>The consortium is offering HK$2.82 a share to buy all shares it doesn't currently hold, representing a 5.6% premium to the stock's last closing price. The offer is final, Razer said.</p>\n<p>Razer, which sells gear for gamers such as keyboards and headphones and has bases in California and Singapore, was founded in 2005 and went public in 2017. Shares are up 12% this year, but remain well below their initial public offering price.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"01337":"雷蛇"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1197247033","content_text":"A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10.79 billion Hong Kong dollars (US$1.38 billion) to take the Hong Kong-listed company private.\nPrivate-equity firm CVC Capital Partners is part of the consortium, Razer said Thursday in a filing to the Hong Kong bourse.\nThe consortium is offering HK$2.82 a share to buy all shares it doesn't currently hold, representing a 5.6% premium to the stock's last closing price. The offer is final, Razer said.\nRazer, which sells gear for gamers such as keyboards and headphones and has bases in California and Singapore, was founded in 2005 and went public in 2017. Shares are up 12% this year, but remain well below their initial public offering price.","news_type":1},"isVote":1,"tweetType":1,"viewCount":569,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":603164518,"gmtCreate":1638375354339,"gmtModify":1638375354511,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Yay tesla&nbsp;","listText":"Yay tesla&nbsp;","text":"Yay tesla","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603164518","repostId":"1121479816","repostType":2,"repost":{"id":"1121479816","weMediaInfo":{"introduction":"Stock Market Quotes, Business News, Financial News, Trading Ideas, and Stock Research by Professionals","home_visible":0,"media_name":"Benzinga","id":"1052270027","head_image":"https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa"},"pubTimestamp":1638360999,"share":"https://www.laohu8.com/m/news/1121479816?lang=&edition=full","pubTime":"2021-12-01 20:16","market":"us","language":"en","title":"Cathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks","url":"https://stock-news.laohu8.com/highlight/detail?id=1121479816","media":"Benzinga","summary":"Cathie Wood’s money managing firm Ark Invest on Tuesday bought 1.11 million shares — estimated to be","content":"<p><b>Cathie Wood</b>’s money managing firm&nbsp;<b>Ark Invest</b>&nbsp;on Tuesday bought 1.11 million shares — estimated to be worth $48.87 million — in&nbsp;<b>Twitter Inc</b>, piling up more shares on the dip&nbsp;just a day after a big leadership change at the social media company.</p>\n<p>Twitter shares&nbsp;closed 4.02% lower at $43.94 a share on Wednesday. The company's stock on Monday rose about 10%&nbsp;but closed down 2.7%.</p>\n<p>Twitter CEO<b>Jack Dorsey</b>&nbsp;said on Monday he was stepping down from his role and handing over the reins to Chief Technology Officer&nbsp;<b>Parag Agrawal,</b>with&nbsp;Bret Taylor serving as the chairman of the board.</p>\n<p>Dorsey, who co-founded Twitter in 2006, also serves as CEO of payments processing company&nbsp;<b>Square Inc.</b></p>\n<p>Analysts at various brokerages presented a mixed view on the change in leadership.</p>\n<p>Wedbush lowered the price target to $52 from $69 on the stock and reiterated a Neutral rating. Jefferies analystBrent Thillsees the move as a \"step in the right direction\" but believes \"plenty of hurdles to clear\" for Twitter to reverse its stock underperformance.</p>\n<p>Three Ark Invest ETFs — the&nbsp;Ark Innovation ETF, the&nbsp;Ark Next Generation Internet ETF&nbsp;and the&nbsp;Ark Fintech Innovation ETF&nbsp;— bought shares in the company on Tuesday.</p>\n<p><b>Here are a few other key Ark Invest trades from Tuesday:</b></p>\n<ul>\n <li><b>Sold 30,034 shares — estimated to be worth $34.38 million — in</b>&nbsp;<b>Tesla Inc. TheElon Musk-led company’s stock closed 0.68% higher at $1,144.76 a share.</b></li>\n <li><b>Sold 158,437 shares — estimated to be worth $49.9 million — in</b>&nbsp;<b>Coinbase</b>&nbsp;<b>Global Inc. Stock closed 1.37% lower at $315 a share.</b></li>\n <li><b>Bought 837,248 shares — estimated to be worth $21.72 million — in</b>&nbsp;<b>Robinhood Markets Inc</b>&nbsp;<b>on the dip. Stock closed 4.17% lower at $25.94 a share.</b></li>\n</ul>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Cathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Benzinga </p>\n<p class=\"h-time\">2021-12-01 20:16</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<p><b>Cathie Wood</b>’s money managing firm&nbsp;<b>Ark Invest</b>&nbsp;on Tuesday bought 1.11 million shares — estimated to be worth $48.87 million — in&nbsp;<b>Twitter Inc</b>, piling up more shares on the dip&nbsp;just a day after a big leadership change at the social media company.</p>\n<p>Twitter shares&nbsp;closed 4.02% lower at $43.94 a share on Wednesday. The company's stock on Monday rose about 10%&nbsp;but closed down 2.7%.</p>\n<p>Twitter CEO<b>Jack Dorsey</b>&nbsp;said on Monday he was stepping down from his role and handing over the reins to Chief Technology Officer&nbsp;<b>Parag Agrawal,</b>with&nbsp;Bret Taylor serving as the chairman of the board.</p>\n<p>Dorsey, who co-founded Twitter in 2006, also serves as CEO of payments processing company&nbsp;<b>Square Inc.</b></p>\n<p>Analysts at various brokerages presented a mixed view on the change in leadership.</p>\n<p>Wedbush lowered the price target to $52 from $69 on the stock and reiterated a Neutral rating. Jefferies analystBrent Thillsees the move as a \"step in the right direction\" but believes \"plenty of hurdles to clear\" for Twitter to reverse its stock underperformance.</p>\n<p>Three Ark Invest ETFs — the&nbsp;Ark Innovation ETF, the&nbsp;Ark Next Generation Internet ETF&nbsp;and the&nbsp;Ark Fintech Innovation ETF&nbsp;— bought shares in the company on Tuesday.</p>\n<p><b>Here are a few other key Ark Invest trades from Tuesday:</b></p>\n<ul>\n <li><b>Sold 30,034 shares — estimated to be worth $34.38 million — in</b>&nbsp;<b>Tesla Inc. TheElon Musk-led company’s stock closed 0.68% higher at $1,144.76 a share.</b></li>\n <li><b>Sold 158,437 shares — estimated to be worth $49.9 million — in</b>&nbsp;<b>Coinbase</b>&nbsp;<b>Global Inc. Stock closed 1.37% lower at $315 a share.</b></li>\n <li><b>Bought 837,248 shares — estimated to be worth $21.72 million — in</b>&nbsp;<b>Robinhood Markets Inc</b>&nbsp;<b>on the dip. Stock closed 4.17% lower at $25.94 a share.</b></li>\n</ul>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"ARKW":"ARK Next Generation Internation ETF","ARKF":"ARK Fintech Innovation ETF","TSLA":"特斯拉","HOOD":"Robinhood","TWTR":"Twitter","ARKK":"ARK Innovation ETF","SQ":"Block","COIN":"Coinbase Global, Inc."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1121479816","content_text":"Cathie Wood’s money managing firm Ark Invest on Tuesday bought 1.11 million shares — estimated to be worth $48.87 million — in Twitter Inc, piling up more shares on the dip just a day after a big leadership change at the social media company.\nTwitter shares closed 4.02% lower at $43.94 a share on Wednesday. The company's stock on Monday rose about 10% but closed down 2.7%.\nTwitter CEOJack Dorsey said on Monday he was stepping down from his role and handing over the reins to Chief Technology Officer Parag Agrawal,with Bret Taylor serving as the chairman of the board.\nDorsey, who co-founded Twitter in 2006, also serves as CEO of payments processing company Square Inc.\nAnalysts at various brokerages presented a mixed view on the change in leadership.\nWedbush lowered the price target to $52 from $69 on the stock and reiterated a Neutral rating. Jefferies analystBrent Thillsees the move as a \"step in the right direction\" but believes \"plenty of hurdles to clear\" for Twitter to reverse its stock underperformance.\nThree Ark Invest ETFs — the Ark Innovation ETF, the Ark Next Generation Internet ETF and the Ark Fintech Innovation ETF — bought shares in the company on Tuesday.\nHere are a few other key Ark Invest trades from Tuesday:\n\nSold 30,034 shares — estimated to be worth $34.38 million — in Tesla Inc. TheElon Musk-led company’s stock closed 0.68% higher at $1,144.76 a share.\nSold 158,437 shares — estimated to be worth $49.9 million — in Coinbase Global Inc. Stock closed 1.37% lower at $315 a share.\nBought 837,248 shares — estimated to be worth $21.72 million — in Robinhood Markets Inc on the dip. Stock closed 4.17% lower at $25.94 a share.","news_type":1},"isVote":1,"tweetType":1,"viewCount":513,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":600731859,"gmtCreate":1638196931721,"gmtModify":1638196931880,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing&nbsp;","listText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing&nbsp;","text":"$Novavax(NVAX)$let's go. Will go up with the cases increasing","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/600731859","isVote":1,"tweetType":1,"viewCount":965,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":871128610,"gmtCreate":1637038902795,"gmtModify":1637038924098,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a>&nbsp;ehat is happening! Woah","listText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a>&nbsp;ehat is happening! Woah","text":"$Razer(01337)$ ehat is happening! Woah","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/871128610","isVote":1,"tweetType":1,"viewCount":1016,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":873765705,"gmtCreate":1636988033557,"gmtModify":1636988033688,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","listText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","text":"$Tiger Brokers(TIGR)$cmon cmon let's go up like a helicopter","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/873765705","isVote":1,"tweetType":1,"viewCount":471,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":851460065,"gmtCreate":1634922504270,"gmtModify":1634922504396,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a>&nbsp;anyone considering keeping till next week?&nbsp;","listText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a>&nbsp;anyone considering keeping till next week?&nbsp;","text":"$Digital World Acquisition Corp(DWAC)$ anyone considering keeping till next week?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":4,"repostSize":0,"link":"https://laohu8.com/post/851460065","isVote":1,"tweetType":1,"viewCount":3011,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498208,"gmtCreate":1634719138359,"gmtModify":1634719138493,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Sigh&nbsp;","listText":"Sigh&nbsp;","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498208","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1},"isVote":1,"tweetType":1,"viewCount":534,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498813,"gmtCreate":1634719131861,"gmtModify":1634719132032,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Sigh&nbsp;","listText":"Sigh&nbsp;","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498813","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1},"isVote":1,"tweetType":1,"viewCount":634,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"hots":[{"id":851460065,"gmtCreate":1634922504270,"gmtModify":1634922504396,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a>&nbsp;anyone considering keeping till next week?&nbsp;","listText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a>&nbsp;anyone considering keeping till next week?&nbsp;","text":"$Digital World Acquisition Corp(DWAC)$ anyone considering keeping till next week?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":4,"repostSize":0,"link":"https://laohu8.com/post/851460065","isVote":1,"tweetType":1,"viewCount":3011,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":873765705,"gmtCreate":1636988033557,"gmtModify":1636988033688,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","listText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","text":"$Tiger Brokers(TIGR)$cmon cmon let's go up like a helicopter","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/873765705","isVote":1,"tweetType":1,"viewCount":471,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":600731859,"gmtCreate":1638196931721,"gmtModify":1638196931880,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing&nbsp;","listText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing&nbsp;","text":"$Novavax(NVAX)$let's go. Will go up with the cases increasing","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/600731859","isVote":1,"tweetType":1,"viewCount":965,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":871128610,"gmtCreate":1637038902795,"gmtModify":1637038924098,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a>&nbsp;ehat is happening! Woah","listText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a>&nbsp;ehat is happening! Woah","text":"$Razer(01337)$ ehat is happening! Woah","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/871128610","isVote":1,"tweetType":1,"viewCount":1016,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498208,"gmtCreate":1634719138359,"gmtModify":1634719138493,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Sigh&nbsp;","listText":"Sigh&nbsp;","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498208","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1},"isVote":1,"tweetType":1,"viewCount":534,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498813,"gmtCreate":1634719131861,"gmtModify":1634719132032,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Sigh&nbsp;","listText":"Sigh&nbsp;","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498813","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1},"isVote":1,"tweetType":1,"viewCount":634,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":607985689,"gmtCreate":1639474734030,"gmtModify":1639474734131,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.&nbsp;","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.&nbsp;","text":"$Tesla Motors(TSLA)$ tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/607985689","isVote":1,"tweetType":1,"viewCount":1003,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":698921927,"gmtCreate":1640279658930,"gmtModify":1640279659074,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;arggh regret not adding more when it was 900 ish but well","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a>&nbsp;arggh regret not adding more when it was 900 ish but well","text":"$Tesla Motors(TSLA)$ arggh regret not adding more when it was 900 ish but well","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/698921927","isVote":1,"tweetType":1,"viewCount":940,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":603265914,"gmtCreate":1638414923445,"gmtModify":1638415187321,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Surprised the price dropped so low. Tot it would stay around the offer px","listText":"Surprised the price dropped so low. Tot it would stay around the offer px","text":"Surprised the price dropped so low. Tot it would stay around the offer px","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603265914","repostId":"1197247033","repostType":2,"repost":{"id":"1197247033","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1638406745,"share":"https://www.laohu8.com/m/news/1197247033?lang=&edition=full","pubTime":"2021-12-02 08:59","market":"hk","language":"en","title":"Razer will be privatized at a price of HK $2.82 per share","url":"https://stock-news.laohu8.com/highlight/detail?id=1197247033","media":"Tiger Newspress","summary":"A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10","content":"<p>A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10.79 billion Hong Kong dollars (US$1.38 billion) to take the Hong Kong-listed company private.</p>\n<p>Private-equity firm CVC Capital Partners is part of the consortium, Razer said Thursday in a filing to the Hong Kong bourse.</p>\n<p>The consortium is offering HK$2.82 a share to buy all shares it doesn't currently hold, representing a 5.6% premium to the stock's last closing price. The offer is final, Razer said.</p>\n<p>Razer, which sells gear for gamers such as keyboards and headphones and has bases in California and Singapore, was founded in 2005 and went public in 2017. Shares are up 12% this year, but remain well below their initial public offering price.</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Razer will be privatized at a price of HK $2.82 per share</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nRazer will be privatized at a price of HK $2.82 per share\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-12-02 08:59</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10.79 billion Hong Kong dollars (US$1.38 billion) to take the Hong Kong-listed company private.</p>\n<p>Private-equity firm CVC Capital Partners is part of the consortium, Razer said Thursday in a filing to the Hong Kong bourse.</p>\n<p>The consortium is offering HK$2.82 a share to buy all shares it doesn't currently hold, representing a 5.6% premium to the stock's last closing price. The offer is final, Razer said.</p>\n<p>Razer, which sells gear for gamers such as keyboards and headphones and has bases in California and Singapore, was founded in 2005 and went public in 2017. Shares are up 12% this year, but remain well below their initial public offering price.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"01337":"雷蛇"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1197247033","content_text":"A consortium led by the founders of gaming equipment maker Razer Inc. have made an offer of up to 10.79 billion Hong Kong dollars (US$1.38 billion) to take the Hong Kong-listed company private.\nPrivate-equity firm CVC Capital Partners is part of the consortium, Razer said Thursday in a filing to the Hong Kong bourse.\nThe consortium is offering HK$2.82 a share to buy all shares it doesn't currently hold, representing a 5.6% premium to the stock's last closing price. The offer is final, Razer said.\nRazer, which sells gear for gamers such as keyboards and headphones and has bases in California and Singapore, was founded in 2005 and went public in 2017. Shares are up 12% this year, but remain well below their initial public offering price.","news_type":1},"isVote":1,"tweetType":1,"viewCount":569,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":603164518,"gmtCreate":1638375354339,"gmtModify":1638375354511,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Yay tesla&nbsp;","listText":"Yay tesla&nbsp;","text":"Yay tesla","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603164518","repostId":"1121479816","repostType":2,"repost":{"id":"1121479816","weMediaInfo":{"introduction":"Stock Market Quotes, Business News, Financial News, Trading Ideas, and Stock Research by Professionals","home_visible":0,"media_name":"Benzinga","id":"1052270027","head_image":"https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa"},"pubTimestamp":1638360999,"share":"https://www.laohu8.com/m/news/1121479816?lang=&edition=full","pubTime":"2021-12-01 20:16","market":"us","language":"en","title":"Cathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks","url":"https://stock-news.laohu8.com/highlight/detail?id=1121479816","media":"Benzinga","summary":"Cathie Wood’s money managing firm Ark Invest on Tuesday bought 1.11 million shares — estimated to be","content":"<p><b>Cathie Wood</b>’s money managing firm&nbsp;<b>Ark Invest</b>&nbsp;on Tuesday bought 1.11 million shares — estimated to be worth $48.87 million — in&nbsp;<b>Twitter Inc</b>, piling up more shares on the dip&nbsp;just a day after a big leadership change at the social media company.</p>\n<p>Twitter shares&nbsp;closed 4.02% lower at $43.94 a share on Wednesday. The company's stock on Monday rose about 10%&nbsp;but closed down 2.7%.</p>\n<p>Twitter CEO<b>Jack Dorsey</b>&nbsp;said on Monday he was stepping down from his role and handing over the reins to Chief Technology Officer&nbsp;<b>Parag Agrawal,</b>with&nbsp;Bret Taylor serving as the chairman of the board.</p>\n<p>Dorsey, who co-founded Twitter in 2006, also serves as CEO of payments processing company&nbsp;<b>Square Inc.</b></p>\n<p>Analysts at various brokerages presented a mixed view on the change in leadership.</p>\n<p>Wedbush lowered the price target to $52 from $69 on the stock and reiterated a Neutral rating. Jefferies analystBrent Thillsees the move as a \"step in the right direction\" but believes \"plenty of hurdles to clear\" for Twitter to reverse its stock underperformance.</p>\n<p>Three Ark Invest ETFs — the&nbsp;Ark Innovation ETF, the&nbsp;Ark Next Generation Internet ETF&nbsp;and the&nbsp;Ark Fintech Innovation ETF&nbsp;— bought shares in the company on Tuesday.</p>\n<p><b>Here are a few other key Ark Invest trades from Tuesday:</b></p>\n<ul>\n <li><b>Sold 30,034 shares — estimated to be worth $34.38 million — in</b>&nbsp;<b>Tesla Inc. TheElon Musk-led company’s stock closed 0.68% higher at $1,144.76 a share.</b></li>\n <li><b>Sold 158,437 shares — estimated to be worth $49.9 million — in</b>&nbsp;<b>Coinbase</b>&nbsp;<b>Global Inc. Stock closed 1.37% lower at $315 a share.</b></li>\n <li><b>Bought 837,248 shares — estimated to be worth $21.72 million — in</b>&nbsp;<b>Robinhood Markets Inc</b>&nbsp;<b>on the dip. Stock closed 4.17% lower at $25.94 a share.</b></li>\n</ul>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Cathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCathie Wood Sells $34M In Tesla And Loads Up On Twitter And These 2 Stocks\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Benzinga </p>\n<p class=\"h-time\">2021-12-01 20:16</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<p><b>Cathie Wood</b>’s money managing firm&nbsp;<b>Ark Invest</b>&nbsp;on Tuesday bought 1.11 million shares — estimated to be worth $48.87 million — in&nbsp;<b>Twitter Inc</b>, piling up more shares on the dip&nbsp;just a day after a big leadership change at the social media company.</p>\n<p>Twitter shares&nbsp;closed 4.02% lower at $43.94 a share on Wednesday. The company's stock on Monday rose about 10%&nbsp;but closed down 2.7%.</p>\n<p>Twitter CEO<b>Jack Dorsey</b>&nbsp;said on Monday he was stepping down from his role and handing over the reins to Chief Technology Officer&nbsp;<b>Parag Agrawal,</b>with&nbsp;Bret Taylor serving as the chairman of the board.</p>\n<p>Dorsey, who co-founded Twitter in 2006, also serves as CEO of payments processing company&nbsp;<b>Square Inc.</b></p>\n<p>Analysts at various brokerages presented a mixed view on the change in leadership.</p>\n<p>Wedbush lowered the price target to $52 from $69 on the stock and reiterated a Neutral rating. Jefferies analystBrent Thillsees the move as a \"step in the right direction\" but believes \"plenty of hurdles to clear\" for Twitter to reverse its stock underperformance.</p>\n<p>Three Ark Invest ETFs — the&nbsp;Ark Innovation ETF, the&nbsp;Ark Next Generation Internet ETF&nbsp;and the&nbsp;Ark Fintech Innovation ETF&nbsp;— bought shares in the company on Tuesday.</p>\n<p><b>Here are a few other key Ark Invest trades from Tuesday:</b></p>\n<ul>\n <li><b>Sold 30,034 shares — estimated to be worth $34.38 million — in</b>&nbsp;<b>Tesla Inc. TheElon Musk-led company’s stock closed 0.68% higher at $1,144.76 a share.</b></li>\n <li><b>Sold 158,437 shares — estimated to be worth $49.9 million — in</b>&nbsp;<b>Coinbase</b>&nbsp;<b>Global Inc. Stock closed 1.37% lower at $315 a share.</b></li>\n <li><b>Bought 837,248 shares — estimated to be worth $21.72 million — in</b>&nbsp;<b>Robinhood Markets Inc</b>&nbsp;<b>on the dip. Stock closed 4.17% lower at $25.94 a share.</b></li>\n</ul>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"ARKW":"ARK Next Generation Internation ETF","ARKF":"ARK Fintech Innovation ETF","TSLA":"特斯拉","HOOD":"Robinhood","TWTR":"Twitter","ARKK":"ARK Innovation ETF","SQ":"Block","COIN":"Coinbase Global, Inc."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1121479816","content_text":"Cathie Wood’s money managing firm Ark Invest on Tuesday bought 1.11 million shares — estimated to be worth $48.87 million — in Twitter Inc, piling up more shares on the dip just a day after a big leadership change at the social media company.\nTwitter shares closed 4.02% lower at $43.94 a share on Wednesday. The company's stock on Monday rose about 10% but closed down 2.7%.\nTwitter CEOJack Dorsey said on Monday he was stepping down from his role and handing over the reins to Chief Technology Officer Parag Agrawal,with Bret Taylor serving as the chairman of the board.\nDorsey, who co-founded Twitter in 2006, also serves as CEO of payments processing company Square Inc.\nAnalysts at various brokerages presented a mixed view on the change in leadership.\nWedbush lowered the price target to $52 from $69 on the stock and reiterated a Neutral rating. Jefferies analystBrent Thillsees the move as a \"step in the right direction\" but believes \"plenty of hurdles to clear\" for Twitter to reverse its stock underperformance.\nThree Ark Invest ETFs — the Ark Innovation ETF, the Ark Next Generation Internet ETF and the Ark Fintech Innovation ETF — bought shares in the company on Tuesday.\nHere are a few other key Ark Invest trades from Tuesday:\n\nSold 30,034 shares — estimated to be worth $34.38 million — in Tesla Inc. TheElon Musk-led company’s stock closed 0.68% higher at $1,144.76 a share.\nSold 158,437 shares — estimated to be worth $49.9 million — in Coinbase Global Inc. Stock closed 1.37% lower at $315 a share.\nBought 837,248 shares — estimated to be worth $21.72 million — in Robinhood Markets Inc on the dip. Stock closed 4.17% lower at $25.94 a share.","news_type":1},"isVote":1,"tweetType":1,"viewCount":513,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"lives":[]}