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2021-11-30

Nice

5 Stocks To Watch For November 30, 2021

2021-11-25

$Assertio Holdings, Inc.(ASRT)$Bullish engulfing.Lets see if there is more volume when the marketopens.

2021-11-05

this is the reason why it dumped

Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors

2021-11-03

$Birks(BGI)$Hmm another parabolic move on 3M TF

2021-11-03

$Baosheng Media Group Holdings(BAOS)$Parabolic move on smaller time frame?

2021-11-03

$Baosheng Media Group Holdings(BAOS)$Parabolic move?

2021-11-01

The from WHO will be on Nov 3.

Ocugen shares jumped 8.8% in premarket trading

2021-10-26

$Histogenics(OCGN)$Looking for more upside while waiting for WHO approval

2021-10-15

$Cipher Mining Inc.(CIFR)$Will it continue to bounce back after creating a higher low from yesterday’s candle?

2021-10-15

$New(NGD)$Should stay above the support (blue line). Then we will see uptrend to retest the resistance line. DYOR

2021-10-14

$Histogenics(OCGN)$Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see a retest on previous high 18.77

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Hewlett Packard Enterprise shares fell 1.2% to $14.43 in premarket trading&nbsp;Tuesday.</li>\n <li><b>UnitedHealth Group Inc</b> (NYSE:UNH) said it sees FY21 adjusted earnings of $18.75 to $18.90 per share on revenue of approximately $287 billion. The company also expects FY22 adjusted EPS of $21.10-$21.60 and revenue of $317 billion to $320 billion. UnitedHealth shares fell 1% to $447.7 in premarket trading&nbsp;Tuesday.</li>\n <li>Analysts are expecting <b>salesforce.com, inc.</b>&nbsp;(NYSE:CRM) to have earned $0.92 per share on revenue of $6.80 billion for the latest quarter. The company will release earnings after the markets close. salesforce.com shares dropped 0.6% to $294.98 in premarket tradingTuesday.</li>\n</ul>\n<ul>\n <li>Chatham Asset Management offered to acquire <b>R. R. Donnelley &amp; Sons Company</b> (NYSE:RRD) for $10.25 per share in cash. R. R. Donnelley shares gained 0.5% to $10.27 in after-hours trading, following a 10% surge in regular trading Monday.</li>\n <li>Analysts expect <b>NetApp, Inc.</b>&nbsp;(NASDAQ:NTAP) to post quarterly earnings at $1.21 per share on revenue of $1.55 billion after the closing bell. NetApp shares rose 0.3% to $91.80 in after-hours trading&nbsp;Monday.</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>5 Stocks To Watch For November 30, 2021</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\">\n5 Stocks To Watch For November 30, 2021\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\">2021-11-30 17:27</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<p>Some of the stocks that may grab investor focus today are:</p>\n<ul>\n <li>Wall Street expects <b>Hewlett Packard Enterprise Company</b>&nbsp;(NYSE:HPE) to report quarterly earnings at $0.48 per share on revenue of $7.38 billion after the closing bell. Hewlett Packard Enterprise shares fell 1.2% to $14.43 in premarket trading&nbsp;Tuesday.</li>\n <li><b>UnitedHealth Group Inc</b> (NYSE:UNH) said it sees FY21 adjusted earnings of $18.75 to $18.90 per share on revenue of approximately $287 billion. The company also expects FY22 adjusted EPS of $21.10-$21.60 and revenue of $317 billion to $320 billion. UnitedHealth shares fell 1% to $447.7 in premarket trading&nbsp;Tuesday.</li>\n <li>Analysts are expecting <b>salesforce.com, inc.</b>&nbsp;(NYSE:CRM) to have earned $0.92 per share on revenue of $6.80 billion for the latest quarter. The company will release earnings after the markets close. salesforce.com shares dropped 0.6% to $294.98 in premarket tradingTuesday.</li>\n</ul>\n<ul>\n <li>Chatham Asset Management offered to acquire <b>R. R. Donnelley &amp; Sons Company</b> (NYSE:RRD) for $10.25 per share in cash. R. R. Donnelley shares gained 0.5% to $10.27 in after-hours trading, following a 10% surge in regular trading Monday.</li>\n <li>Analysts expect <b>NetApp, Inc.</b>&nbsp;(NASDAQ:NTAP) to post quarterly earnings at $1.21 per share on revenue of $1.55 billion after the closing bell. NetApp shares rose 0.3% to $91.80 in after-hours trading&nbsp;Monday.</li>\n</ul>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BK4535":"淡马锡持仓","BK4087":"商业印刷","BK4548":"巴美列捷福持仓","RRD":"当纳利","BK4170":"电脑硬件、储存设备及电脑周边","UNH":"联合健康","BK4538":"云计算","BK4505":"高瓴资本持仓","BK4567":"ESG概念","HPE":"慧与科技","BK4527":"明星科技股","BK4528":"SaaS概念","CRM":"赛富时","NTAP":"美国网存","BK4154":"管理型保健护理","BK4566":"资本集团","BK4515":"5G概念"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2187586148","content_text":"Some of the stocks that may grab investor focus today are:\n\nWall Street expects Hewlett Packard Enterprise Company (NYSE:HPE) to report quarterly earnings at $0.48 per share on revenue of $7.38 billion after the closing bell. Hewlett Packard Enterprise shares fell 1.2% to $14.43 in premarket trading Tuesday.\nUnitedHealth Group Inc (NYSE:UNH) said it sees FY21 adjusted earnings of $18.75 to $18.90 per share on revenue of approximately $287 billion. The company also expects FY22 adjusted EPS of $21.10-$21.60 and revenue of $317 billion to $320 billion. UnitedHealth shares fell 1% to $447.7 in premarket trading Tuesday.\nAnalysts are expecting salesforce.com, inc. (NYSE:CRM) to have earned $0.92 per share on revenue of $6.80 billion for the latest quarter. The company will release earnings after the markets close. salesforce.com shares dropped 0.6% to $294.98 in premarket tradingTuesday.\n\n\nChatham Asset Management offered to acquire R. R. Donnelley & Sons Company (NYSE:RRD) for $10.25 per share in cash. R. R. Donnelley shares gained 0.5% to $10.27 in after-hours trading, following a 10% surge in regular trading Monday.\nAnalysts expect NetApp, Inc. (NASDAQ:NTAP) to post quarterly earnings at $1.21 per share on revenue of $1.55 billion after the closing bell. NetApp shares rose 0.3% to $91.80 in after-hours trading Monday.","news_type":1},"isVote":1,"tweetType":1,"viewCount":495,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":877906693,"gmtCreate":1637853047935,"gmtModify":1637853048026,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/ASRT\">$Assertio Holdings, Inc.(ASRT)$</a>Bullish engulfing.Lets see if there is more volume when the marketopens.","listText":"<a href=\"https://laohu8.com/S/ASRT\">$Assertio Holdings, Inc.(ASRT)$</a>Bullish engulfing.Lets see if there is more volume when the marketopens.","text":"$Assertio Holdings, Inc.(ASRT)$Bullish engulfing.Lets see if there is more volume when the marketopens.","images":[{"img":"https://static.tigerbbs.com/9399d3060c23665d1cf40f5c800f5567","width":"1125","height":"2839"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/877906693","isVote":1,"tweetType":1,"viewCount":433,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":846974760,"gmtCreate":1636043917939,"gmtModify":1636043918042,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"this is the reason why it dumped","listText":"this is the reason why it dumped","text":"this is the reason why it dumped","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/846974760","repostId":"1168874793","repostType":2,"repost":{"id":"1168874793","pubTimestamp":1636035446,"share":"https://www.laohu8.com/m/news/1168874793?lang=&edition=full","pubTime":"2021-11-04 22:17","market":"us","language":"en","title":"Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors","url":"https://stock-news.laohu8.com/highlight/detail?id=1168874793","media":"Seeking Alpha","summary":"Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US ","content":"<p><b>Summary</b></p>\n<ul>\n <li>Ocugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.</li>\n <li>Meanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.</li>\n <li>There are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up &gt;4,000% in the past year, but has trodden water for several months.</li>\n <li>It's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.</li>\n</ul>\n<p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/25648bf13e5cb82880f748129c72261c\" tg-width=\"1536\" tg-height=\"1024\" width=\"100%\" height=\"auto\"><span>Klaus Vedfelt/DigitalVision via Getty Images</span></p>\n<p><b>Investment Thesis</b></p>\n<p>Bharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.</p>\n<p>As most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.</p>\n<p>Ocugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.</p>\n<p>In this post I recap the full story, updated from my&nbsp;last post in June, and offer some ways to think about Ocugen's share price in the short and long term.</p>\n<p><b>Ocugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far</b></p>\n<p>Ocugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading &lt;$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").</p>\n<p>A delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech&nbsp;became a partner&nbsp;of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.</p>\n<p>I covered the full story in a&nbsp;note on Ocugen&nbsp;back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.</p>\n<p>Unfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.</p>\n<p><b>Ocugen And Bharat Stay The Course - Trials Reveal Strong Efficacy</b></p>\n<p>The bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.</p>\n<p>The results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.</p>\n<p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/862520ed53c876fb96840a3cb9a7a6f9\" tg-width=\"640\" tg-height=\"317\" width=\"100%\" height=\"auto\"><span>Summary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.</span></p>\n<p>As we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.</p>\n<p><b>Bharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada</b></p>\n<p>These results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has&nbsp;dropped as low as 39%&nbsp;in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.</p>\n<p>Ocugen turned its attention to Canada,announcing&nbsp;a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd<b>,</b>allowing for it to submit new data as and when it came in, accelerating the overall review process.</p>\n<p>If approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my&nbsp;last note when providing some discounted cash flow analysis&nbsp;based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.</p>\n<p>The US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\")&nbsp;submission&nbsp;to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:</p>\n<blockquote>\n The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population.\n</blockquote>\n<p>Ocugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.</p>\n<p>Meanwhile, Bharat Biotech&nbsp;received notification&nbsp;today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.</p>\n<p>It's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson &amp; Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.</p>\n<p>Vaccines on the EUL list are permitted to be sent to government's around the world as part of the&nbsp;COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.</p>\n<p><b>Ocugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA</b></p>\n<p>Ocugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.</p>\n<p>That reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.</p>\n<p>Ocugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.</p>\n<p>Ironically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.</p>\n<p>That opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.</p>\n<p>Covaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.</p>\n<p>On the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.</p>\n<p>The fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.</p>\n<p>Nobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.</p>\n<p><b>Conclusion</b></p>\n<p>To summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?</p>\n<p>But how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.</p>\n<p>How much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.</p>\n<p>In conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.</p>\n<p>If I has been holding Ocugen stock since December last year, when it traded at &gt;$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.</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>Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors</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; 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}\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\">\nOcugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-11-04 22:17 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors><strong>Seeking Alpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.\n...</p>\n\n<a href=\"https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"source_url":"https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1168874793","content_text":"Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.\nMeanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.\nThere are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up >4,000% in the past year, but has trodden water for several months.\nIt's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.\n\nKlaus Vedfelt/DigitalVision via Getty Images\nInvestment Thesis\nBharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.\nAs most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.\nOcugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.\nIn this post I recap the full story, updated from my last post in June, and offer some ways to think about Ocugen's share price in the short and long term.\nOcugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far\nOcugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading <$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").\nA delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech became a partner of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.\nI covered the full story in a note on Ocugen back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.\nUnfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.\nOcugen And Bharat Stay The Course - Trials Reveal Strong Efficacy\nThe bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.\nThe results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.\nSummary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.\nAs we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.\nBharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada\nThese results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has dropped as low as 39% in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.\nOcugen turned its attention to Canada,announcing a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd,allowing for it to submit new data as and when it came in, accelerating the overall review process.\nIf approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my last note when providing some discounted cash flow analysis based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.\nThe US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\") submission to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:\n\n The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population.\n\nOcugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.\nMeanwhile, Bharat Biotech received notification today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.\nIt's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson & Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.\nVaccines on the EUL list are permitted to be sent to government's around the world as part of the COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.\nOcugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA\nOcugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.\nThat reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.\nOcugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.\nIronically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.\nThat opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.\nCovaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.\nOn the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.\nThe fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.\nNobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.\nConclusion\nTo summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?\nBut how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.\nHow much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.\nIn conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.\nIf I has been holding Ocugen stock since December last year, when it traded at >$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.","news_type":1},"isVote":1,"tweetType":1,"viewCount":663,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":841977718,"gmtCreate":1635873963161,"gmtModify":1635873963161,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BGI\">$Birks(BGI)$</a>Hmm another parabolic move on 3M TF","listText":"<a href=\"https://laohu8.com/S/BGI\">$Birks(BGI)$</a>Hmm another parabolic move on 3M TF","text":"$Birks(BGI)$Hmm another parabolic move on 3M TF","images":[{"img":"https://static.tigerbbs.com/95d5cf7adb845655d68e4efeeb481fc0","width":"1125","height":"2915"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/841977718","isVote":1,"tweetType":1,"viewCount":896,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":841977689,"gmtCreate":1635873889386,"gmtModify":1635873889386,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move on smaller time frame?","listText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move on smaller time frame?","text":"$Baosheng Media Group Holdings(BAOS)$Parabolic move on smaller time frame?","images":[{"img":"https://static.tigerbbs.com/3cbcf4e64707dc4ca9280b8e7844293a","width":"1125","height":"2915"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/841977689","isVote":1,"tweetType":1,"viewCount":803,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":841977324,"gmtCreate":1635873833618,"gmtModify":1635873833618,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move?","listText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move?","text":"$Baosheng Media Group Holdings(BAOS)$Parabolic move?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/841977324","isVote":1,"tweetType":1,"viewCount":563,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":849590294,"gmtCreate":1635763928571,"gmtModify":1635763928571,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"The from WHO will be on Nov 3.&nbsp;","listText":"The from WHO will be on Nov 3.&nbsp;","text":"The from WHO will be on Nov 3.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/849590294","repostId":"1150864664","repostType":4,"repost":{"id":"1150864664","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":1635759555,"share":"https://www.laohu8.com/m/news/1150864664?lang=&edition=full","pubTime":"2021-11-01 17:39","market":"us","language":"en","title":"Ocugen shares jumped 8.8% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1150864664","media":"Tiger Newspress","summary":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in ","content":"<p>Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.</p>\n<p><img src=\"https://static.tigerbbs.com/9c40abeceb277bdc16372a037d9cc5f3\" tg-width=\"847\" tg-height=\"618\" width=\"100%\" height=\"auto\"></p>\n<p>Malvern, Pa.-based&nbsp;<b>Ocugen</b>&nbsp;has&nbsp;<b>submitted</b>&nbsp;an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.</p>\n<p>Part of the trial’s&nbsp;goal&nbsp;is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.</p>\n<p>Covaxin&nbsp;is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.</p>\n<p>The vaccine was jointly developed by India’s&nbsp;<b>Bharat Biotech</b>&nbsp;and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.</p>\n<p>The vaccine received emergency authorization in India on January 3, 2021. However, there has been a<b>long delay</b>in authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.</p>\n<p>Although the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.</p>\n<p>Shankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”</p>\n<p>The Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare&nbsp;blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.</p>\n<p>The Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.</p>\n<p>Data from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.</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>Ocugen shares jumped 8.8% 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\">\nOcugen shares jumped 8.8% 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\">2021-11-01 17:39</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.</p>\n<p><img src=\"https://static.tigerbbs.com/9c40abeceb277bdc16372a037d9cc5f3\" tg-width=\"847\" tg-height=\"618\" width=\"100%\" height=\"auto\"></p>\n<p>Malvern, Pa.-based&nbsp;<b>Ocugen</b>&nbsp;has&nbsp;<b>submitted</b>&nbsp;an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.</p>\n<p>Part of the trial’s&nbsp;goal&nbsp;is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.</p>\n<p>Covaxin&nbsp;is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.</p>\n<p>The vaccine was jointly developed by India’s&nbsp;<b>Bharat Biotech</b>&nbsp;and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.</p>\n<p>The vaccine received emergency authorization in India on January 3, 2021. However, there has been a<b>long delay</b>in authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.</p>\n<p>Although the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.</p>\n<p>Shankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”</p>\n<p>The Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare&nbsp;blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.</p>\n<p>The Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.</p>\n<p>Data from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1150864664","content_text":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.\n\nMalvern, Pa.-based Ocugen has submitted an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.\nPart of the trial’s goal is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.\nCovaxin is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.\nThe vaccine was jointly developed by India’s Bharat Biotech and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.\nThe vaccine received emergency authorization in India on January 3, 2021. However, there has been along delayin authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.\nAlthough the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.\nShankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”\nThe Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.\nThe Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.\nData from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.","news_type":1},"isVote":1,"tweetType":1,"viewCount":412,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":852385256,"gmtCreate":1635243219724,"gmtModify":1635243219808,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Looking for more upside while waiting for WHO approval","listText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Looking for more upside while waiting for WHO approval","text":"$Histogenics(OCGN)$Looking for more upside while waiting for WHO approval","images":[{"img":"https://static.tigerbbs.com/6ce3c47380ff674e83d4832f524a4dba","width":"1125","height":"2847"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/852385256","isVote":1,"tweetType":1,"viewCount":421,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":824817376,"gmtCreate":1634301276610,"gmtModify":1634301276690,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/CIFR\">$Cipher Mining Inc.(CIFR)$</a>Will it continue to bounce back after creating a higher low from yesterday’s candle?","listText":"<a href=\"https://laohu8.com/S/CIFR\">$Cipher Mining Inc.(CIFR)$</a>Will it continue to bounce back after creating a higher low from yesterday’s candle?","text":"$Cipher Mining Inc.(CIFR)$Will it continue to bounce back after creating a higher low from yesterday’s candle?","images":[{"img":"https://static.tigerbbs.com/8ebc67569356b96340d3f682e48e3703","width":"1125","height":"2847"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/824817376","isVote":1,"tweetType":1,"viewCount":669,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":825253254,"gmtCreate":1634232723000,"gmtModify":1634232723000,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NGD\">$New(NGD)$</a>Should stay above the&nbsp;support (blue line). Then we will see uptrend to retest the resistance line.&nbsp;DYOR","listText":"<a href=\"https://laohu8.com/S/NGD\">$New(NGD)$</a>Should stay above the&nbsp;support (blue line). Then we will see uptrend to retest the resistance line.&nbsp;DYOR","text":"$New(NGD)$Should stay above the support (blue line). Then we will see uptrend to retest the resistance line. DYOR","images":[{"img":"https://static.tigerbbs.com/6dfa9ac22e0e1960304b3a27a3caa1e8","width":"1125","height":"2671"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/825253254","isVote":1,"tweetType":1,"viewCount":887,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":825632258,"gmtCreate":1634221062375,"gmtModify":1634221736540,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see &nbsp;a retest on previous high 18.77","listText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see &nbsp;a retest on previous high 18.77","text":"$Histogenics(OCGN)$Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see a retest on previous high 18.77","images":[{"img":"https://static.tigerbbs.com/deea9acb44c925904d90664414763f0c","width":"1125","height":"2387"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":3,"repostSize":0,"link":"https://laohu8.com/post/825632258","isVote":1,"tweetType":1,"viewCount":971,"authorTweetTopStatus":1,"verified":2,"comments":[{"author":{"id":"9000000000000367","authorId":"9000000000000367","name":"UriahMcCarthy","avatar":"https://static.tigerbbs.com/755733cbc3b26020a558f49d6dcb6fc4","crmLevel":1,"crmLevelSwitch":0,"idStr":"9000000000000367","authorIdStr":"9000000000000367"},"content":"This is definitely good for SP in the long run. After all, the profit of vaccine is very high","text":"This is definitely good for SP in the long run. After all, the profit of vaccine is very high","html":"This is definitely good for SP in the long run. After all, the profit of vaccine is very high"}],"imageCount":1,"langContent":"CN","totalScore":0}],"hots":[{"id":825632258,"gmtCreate":1634221062375,"gmtModify":1634221736540,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see &nbsp;a retest on previous high 18.77","listText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see &nbsp;a retest on previous high 18.77","text":"$Histogenics(OCGN)$Ocugen Inc. shares were trading higher since tuesday after Indian Government approved Bharat Biotech’s Covid-19 vaccine Covaxin, for children between the ages of 2 and 18. We will see a retest on previous high 18.77","images":[{"img":"https://static.tigerbbs.com/deea9acb44c925904d90664414763f0c","width":"1125","height":"2387"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":3,"repostSize":0,"link":"https://laohu8.com/post/825632258","isVote":1,"tweetType":1,"viewCount":971,"authorTweetTopStatus":1,"verified":2,"comments":[{"author":{"id":"9000000000000367","authorId":"9000000000000367","name":"UriahMcCarthy","avatar":"https://static.tigerbbs.com/755733cbc3b26020a558f49d6dcb6fc4","crmLevel":1,"crmLevelSwitch":0,"idStr":"9000000000000367","authorIdStr":"9000000000000367"},"content":"This is definitely good for SP in the long run. After all, the profit of vaccine is very high","text":"This is definitely good for SP in the long run. After all, the profit of vaccine is very high","html":"This is definitely good for SP in the long run. After all, the profit of vaccine is very high"}],"imageCount":1,"langContent":"CN","totalScore":0},{"id":609882396,"gmtCreate":1638264652492,"gmtModify":1638264751186,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"Nice","listText":"Nice","text":"Nice","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":8,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/609882396","repostId":"2187586148","repostType":2,"repost":{"id":"2187586148","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":1638264468,"share":"https://www.laohu8.com/m/news/2187586148?lang=&edition=full","pubTime":"2021-11-30 17:27","market":"us","language":"en","title":"5 Stocks To Watch For November 30, 2021","url":"https://stock-news.laohu8.com/highlight/detail?id=2187586148","media":"Benzinga","summary":"Some of the stocks that may grab investor focus today are:\n","content":"<p>Some of the stocks that may grab investor focus today are:</p>\n<ul>\n <li>Wall Street expects <b>Hewlett Packard Enterprise Company</b>&nbsp;(NYSE:HPE) to report quarterly earnings at $0.48 per share on revenue of $7.38 billion after the closing bell. Hewlett Packard Enterprise shares fell 1.2% to $14.43 in premarket trading&nbsp;Tuesday.</li>\n <li><b>UnitedHealth Group Inc</b> (NYSE:UNH) said it sees FY21 adjusted earnings of $18.75 to $18.90 per share on revenue of approximately $287 billion. The company also expects FY22 adjusted EPS of $21.10-$21.60 and revenue of $317 billion to $320 billion. UnitedHealth shares fell 1% to $447.7 in premarket trading&nbsp;Tuesday.</li>\n <li>Analysts are expecting <b>salesforce.com, inc.</b>&nbsp;(NYSE:CRM) to have earned $0.92 per share on revenue of $6.80 billion for the latest quarter. The company will release earnings after the markets close. salesforce.com shares dropped 0.6% to $294.98 in premarket tradingTuesday.</li>\n</ul>\n<ul>\n <li>Chatham Asset Management offered to acquire <b>R. R. Donnelley &amp; Sons Company</b> (NYSE:RRD) for $10.25 per share in cash. R. R. Donnelley shares gained 0.5% to $10.27 in after-hours trading, following a 10% surge in regular trading Monday.</li>\n <li>Analysts expect <b>NetApp, Inc.</b>&nbsp;(NASDAQ:NTAP) to post quarterly earnings at $1.21 per share on revenue of $1.55 billion after the closing bell. NetApp shares rose 0.3% to $91.80 in after-hours trading&nbsp;Monday.</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>5 Stocks To Watch For November 30, 2021</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\">\n5 Stocks To Watch For November 30, 2021\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\">2021-11-30 17:27</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<p>Some of the stocks that may grab investor focus today are:</p>\n<ul>\n <li>Wall Street expects <b>Hewlett Packard Enterprise Company</b>&nbsp;(NYSE:HPE) to report quarterly earnings at $0.48 per share on revenue of $7.38 billion after the closing bell. Hewlett Packard Enterprise shares fell 1.2% to $14.43 in premarket trading&nbsp;Tuesday.</li>\n <li><b>UnitedHealth Group Inc</b> (NYSE:UNH) said it sees FY21 adjusted earnings of $18.75 to $18.90 per share on revenue of approximately $287 billion. The company also expects FY22 adjusted EPS of $21.10-$21.60 and revenue of $317 billion to $320 billion. UnitedHealth shares fell 1% to $447.7 in premarket trading&nbsp;Tuesday.</li>\n <li>Analysts are expecting <b>salesforce.com, inc.</b>&nbsp;(NYSE:CRM) to have earned $0.92 per share on revenue of $6.80 billion for the latest quarter. The company will release earnings after the markets close. salesforce.com shares dropped 0.6% to $294.98 in premarket tradingTuesday.</li>\n</ul>\n<ul>\n <li>Chatham Asset Management offered to acquire <b>R. R. Donnelley &amp; Sons Company</b> (NYSE:RRD) for $10.25 per share in cash. R. R. Donnelley shares gained 0.5% to $10.27 in after-hours trading, following a 10% surge in regular trading Monday.</li>\n <li>Analysts expect <b>NetApp, Inc.</b>&nbsp;(NASDAQ:NTAP) to post quarterly earnings at $1.21 per share on revenue of $1.55 billion after the closing bell. NetApp shares rose 0.3% to $91.80 in after-hours trading&nbsp;Monday.</li>\n</ul>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BK4535":"淡马锡持仓","BK4087":"商业印刷","BK4548":"巴美列捷福持仓","RRD":"当纳利","BK4170":"电脑硬件、储存设备及电脑周边","UNH":"联合健康","BK4538":"云计算","BK4505":"高瓴资本持仓","BK4567":"ESG概念","HPE":"慧与科技","BK4527":"明星科技股","BK4528":"SaaS概念","CRM":"赛富时","NTAP":"美国网存","BK4154":"管理型保健护理","BK4566":"资本集团","BK4515":"5G概念"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2187586148","content_text":"Some of the stocks that may grab investor focus today are:\n\nWall Street expects Hewlett Packard Enterprise Company (NYSE:HPE) to report quarterly earnings at $0.48 per share on revenue of $7.38 billion after the closing bell. Hewlett Packard Enterprise shares fell 1.2% to $14.43 in premarket trading Tuesday.\nUnitedHealth Group Inc (NYSE:UNH) said it sees FY21 adjusted earnings of $18.75 to $18.90 per share on revenue of approximately $287 billion. The company also expects FY22 adjusted EPS of $21.10-$21.60 and revenue of $317 billion to $320 billion. UnitedHealth shares fell 1% to $447.7 in premarket trading Tuesday.\nAnalysts are expecting salesforce.com, inc. (NYSE:CRM) to have earned $0.92 per share on revenue of $6.80 billion for the latest quarter. The company will release earnings after the markets close. salesforce.com shares dropped 0.6% to $294.98 in premarket tradingTuesday.\n\n\nChatham Asset Management offered to acquire R. R. Donnelley & Sons Company (NYSE:RRD) for $10.25 per share in cash. R. R. Donnelley shares gained 0.5% to $10.27 in after-hours trading, following a 10% surge in regular trading Monday.\nAnalysts expect NetApp, Inc. (NASDAQ:NTAP) to post quarterly earnings at $1.21 per share on revenue of $1.55 billion after the closing bell. NetApp shares rose 0.3% to $91.80 in after-hours trading Monday.","news_type":1},"isVote":1,"tweetType":1,"viewCount":495,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":841977689,"gmtCreate":1635873889386,"gmtModify":1635873889386,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move on smaller time frame?","listText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move on smaller time frame?","text":"$Baosheng Media Group Holdings(BAOS)$Parabolic move on smaller time frame?","images":[{"img":"https://static.tigerbbs.com/3cbcf4e64707dc4ca9280b8e7844293a","width":"1125","height":"2915"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/841977689","isVote":1,"tweetType":1,"viewCount":803,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":841977324,"gmtCreate":1635873833618,"gmtModify":1635873833618,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move?","listText":"<a href=\"https://laohu8.com/S/BAOS\">$Baosheng Media Group Holdings(BAOS)$</a>Parabolic move?","text":"$Baosheng Media Group Holdings(BAOS)$Parabolic move?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/841977324","isVote":1,"tweetType":1,"viewCount":563,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":877906693,"gmtCreate":1637853047935,"gmtModify":1637853048026,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/ASRT\">$Assertio Holdings, Inc.(ASRT)$</a>Bullish engulfing.Lets see if there is more volume when the marketopens.","listText":"<a href=\"https://laohu8.com/S/ASRT\">$Assertio Holdings, Inc.(ASRT)$</a>Bullish engulfing.Lets see if there is more volume when the marketopens.","text":"$Assertio Holdings, Inc.(ASRT)$Bullish engulfing.Lets see if there is more volume when the marketopens.","images":[{"img":"https://static.tigerbbs.com/9399d3060c23665d1cf40f5c800f5567","width":"1125","height":"2839"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/877906693","isVote":1,"tweetType":1,"viewCount":433,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":846974760,"gmtCreate":1636043917939,"gmtModify":1636043918042,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"this is the reason why it dumped","listText":"this is the reason why it dumped","text":"this is the reason why it dumped","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/846974760","repostId":"1168874793","repostType":2,"repost":{"id":"1168874793","pubTimestamp":1636035446,"share":"https://www.laohu8.com/m/news/1168874793?lang=&edition=full","pubTime":"2021-11-04 22:17","market":"us","language":"en","title":"Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors","url":"https://stock-news.laohu8.com/highlight/detail?id=1168874793","media":"Seeking Alpha","summary":"Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US ","content":"<p><b>Summary</b></p>\n<ul>\n <li>Ocugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.</li>\n <li>Meanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.</li>\n <li>There are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up &gt;4,000% in the past year, but has trodden water for several months.</li>\n <li>It's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.</li>\n</ul>\n<p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/25648bf13e5cb82880f748129c72261c\" tg-width=\"1536\" tg-height=\"1024\" width=\"100%\" height=\"auto\"><span>Klaus Vedfelt/DigitalVision via Getty Images</span></p>\n<p><b>Investment Thesis</b></p>\n<p>Bharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.</p>\n<p>As most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.</p>\n<p>Ocugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.</p>\n<p>In this post I recap the full story, updated from my&nbsp;last post in June, and offer some ways to think about Ocugen's share price in the short and long term.</p>\n<p><b>Ocugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far</b></p>\n<p>Ocugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading &lt;$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").</p>\n<p>A delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech&nbsp;became a partner&nbsp;of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.</p>\n<p>I covered the full story in a&nbsp;note on Ocugen&nbsp;back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.</p>\n<p>Unfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.</p>\n<p><b>Ocugen And Bharat Stay The Course - Trials Reveal Strong Efficacy</b></p>\n<p>The bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.</p>\n<p>The results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.</p>\n<p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/862520ed53c876fb96840a3cb9a7a6f9\" tg-width=\"640\" tg-height=\"317\" width=\"100%\" height=\"auto\"><span>Summary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.</span></p>\n<p>As we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.</p>\n<p><b>Bharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada</b></p>\n<p>These results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has&nbsp;dropped as low as 39%&nbsp;in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.</p>\n<p>Ocugen turned its attention to Canada,announcing&nbsp;a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd<b>,</b>allowing for it to submit new data as and when it came in, accelerating the overall review process.</p>\n<p>If approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my&nbsp;last note when providing some discounted cash flow analysis&nbsp;based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.</p>\n<p>The US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\")&nbsp;submission&nbsp;to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:</p>\n<blockquote>\n The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population.\n</blockquote>\n<p>Ocugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.</p>\n<p>Meanwhile, Bharat Biotech&nbsp;received notification&nbsp;today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.</p>\n<p>It's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson &amp; Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.</p>\n<p>Vaccines on the EUL list are permitted to be sent to government's around the world as part of the&nbsp;COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.</p>\n<p><b>Ocugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA</b></p>\n<p>Ocugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.</p>\n<p>That reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.</p>\n<p>Ocugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.</p>\n<p>Ironically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.</p>\n<p>That opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.</p>\n<p>Covaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.</p>\n<p>On the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.</p>\n<p>The fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.</p>\n<p>Nobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.</p>\n<p><b>Conclusion</b></p>\n<p>To summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?</p>\n<p>But how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.</p>\n<p>How much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.</p>\n<p>In conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.</p>\n<p>If I has been holding Ocugen stock since December last year, when it traded at &gt;$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.</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>Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors</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\">\nOcugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-11-04 22:17 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors><strong>Seeking Alpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.\n...</p>\n\n<a href=\"https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"source_url":"https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1168874793","content_text":"Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.\nMeanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.\nThere are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up >4,000% in the past year, but has trodden water for several months.\nIt's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.\n\nKlaus Vedfelt/DigitalVision via Getty Images\nInvestment Thesis\nBharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.\nAs most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.\nOcugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.\nIn this post I recap the full story, updated from my last post in June, and offer some ways to think about Ocugen's share price in the short and long term.\nOcugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far\nOcugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading <$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").\nA delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech became a partner of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.\nI covered the full story in a note on Ocugen back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.\nUnfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.\nOcugen And Bharat Stay The Course - Trials Reveal Strong Efficacy\nThe bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.\nThe results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.\nSummary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.\nAs we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.\nBharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada\nThese results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has dropped as low as 39% in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.\nOcugen turned its attention to Canada,announcing a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd,allowing for it to submit new data as and when it came in, accelerating the overall review process.\nIf approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my last note when providing some discounted cash flow analysis based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.\nThe US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\") submission to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:\n\n The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population.\n\nOcugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.\nMeanwhile, Bharat Biotech received notification today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.\nIt's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson & Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.\nVaccines on the EUL list are permitted to be sent to government's around the world as part of the COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.\nOcugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA\nOcugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.\nThat reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.\nOcugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.\nIronically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.\nThat opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.\nCovaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.\nOn the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.\nThe fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.\nNobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.\nConclusion\nTo summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?\nBut how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.\nHow much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.\nIn conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.\nIf I has been holding Ocugen stock since December last year, when it traded at >$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.","news_type":1},"isVote":1,"tweetType":1,"viewCount":663,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":841977718,"gmtCreate":1635873963161,"gmtModify":1635873963161,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BGI\">$Birks(BGI)$</a>Hmm another parabolic move on 3M TF","listText":"<a href=\"https://laohu8.com/S/BGI\">$Birks(BGI)$</a>Hmm another parabolic move on 3M TF","text":"$Birks(BGI)$Hmm another parabolic move on 3M TF","images":[{"img":"https://static.tigerbbs.com/95d5cf7adb845655d68e4efeeb481fc0","width":"1125","height":"2915"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/841977718","isVote":1,"tweetType":1,"viewCount":896,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":849590294,"gmtCreate":1635763928571,"gmtModify":1635763928571,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"The from WHO will be on Nov 3.&nbsp;","listText":"The from WHO will be on Nov 3.&nbsp;","text":"The from WHO will be on Nov 3.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/849590294","repostId":"1150864664","repostType":4,"repost":{"id":"1150864664","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":1635759555,"share":"https://www.laohu8.com/m/news/1150864664?lang=&edition=full","pubTime":"2021-11-01 17:39","market":"us","language":"en","title":"Ocugen shares jumped 8.8% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1150864664","media":"Tiger Newspress","summary":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in ","content":"<p>Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.</p>\n<p><img src=\"https://static.tigerbbs.com/9c40abeceb277bdc16372a037d9cc5f3\" tg-width=\"847\" tg-height=\"618\" width=\"100%\" height=\"auto\"></p>\n<p>Malvern, Pa.-based&nbsp;<b>Ocugen</b>&nbsp;has&nbsp;<b>submitted</b>&nbsp;an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.</p>\n<p>Part of the trial’s&nbsp;goal&nbsp;is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.</p>\n<p>Covaxin&nbsp;is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.</p>\n<p>The vaccine was jointly developed by India’s&nbsp;<b>Bharat Biotech</b>&nbsp;and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.</p>\n<p>The vaccine received emergency authorization in India on January 3, 2021. However, there has been a<b>long delay</b>in authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.</p>\n<p>Although the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.</p>\n<p>Shankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”</p>\n<p>The Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare&nbsp;blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.</p>\n<p>The Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.</p>\n<p>Data from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.</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>Ocugen shares jumped 8.8% 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\">\nOcugen shares jumped 8.8% 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\">2021-11-01 17:39</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.</p>\n<p><img src=\"https://static.tigerbbs.com/9c40abeceb277bdc16372a037d9cc5f3\" tg-width=\"847\" tg-height=\"618\" width=\"100%\" height=\"auto\"></p>\n<p>Malvern, Pa.-based&nbsp;<b>Ocugen</b>&nbsp;has&nbsp;<b>submitted</b>&nbsp;an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.</p>\n<p>Part of the trial’s&nbsp;goal&nbsp;is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.</p>\n<p>Covaxin&nbsp;is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.</p>\n<p>The vaccine was jointly developed by India’s&nbsp;<b>Bharat Biotech</b>&nbsp;and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.</p>\n<p>The vaccine received emergency authorization in India on January 3, 2021. However, there has been a<b>long delay</b>in authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.</p>\n<p>Although the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.</p>\n<p>Shankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”</p>\n<p>The Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare&nbsp;blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.</p>\n<p>The Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.</p>\n<p>Data from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1150864664","content_text":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.\n\nMalvern, Pa.-based Ocugen has submitted an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.\nPart of the trial’s goal is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.\nCovaxin is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.\nThe vaccine was jointly developed by India’s Bharat Biotech and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.\nThe vaccine received emergency authorization in India on January 3, 2021. However, there has been along delayin authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.\nAlthough the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.\nShankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”\nThe Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.\nThe Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.\nData from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.","news_type":1},"isVote":1,"tweetType":1,"viewCount":412,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":852385256,"gmtCreate":1635243219724,"gmtModify":1635243219808,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Looking for more upside while waiting for WHO approval","listText":"<a href=\"https://laohu8.com/S/OCGN\">$Histogenics(OCGN)$</a>Looking for more upside while waiting for WHO approval","text":"$Histogenics(OCGN)$Looking for more upside while waiting for WHO approval","images":[{"img":"https://static.tigerbbs.com/6ce3c47380ff674e83d4832f524a4dba","width":"1125","height":"2847"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/852385256","isVote":1,"tweetType":1,"viewCount":421,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":824817376,"gmtCreate":1634301276610,"gmtModify":1634301276690,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/CIFR\">$Cipher Mining Inc.(CIFR)$</a>Will it continue to bounce back after creating a higher low from yesterday’s candle?","listText":"<a href=\"https://laohu8.com/S/CIFR\">$Cipher Mining Inc.(CIFR)$</a>Will it continue to bounce back after creating a higher low from yesterday’s candle?","text":"$Cipher Mining Inc.(CIFR)$Will it continue to bounce back after creating a higher low from yesterday’s candle?","images":[{"img":"https://static.tigerbbs.com/8ebc67569356b96340d3f682e48e3703","width":"1125","height":"2847"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/824817376","isVote":1,"tweetType":1,"viewCount":669,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0},{"id":825253254,"gmtCreate":1634232723000,"gmtModify":1634232723000,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4095811186634540","authorIdStr":"4095811186634540"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NGD\">$New(NGD)$</a>Should stay above the&nbsp;support (blue line). Then we will see uptrend to retest the resistance line.&nbsp;DYOR","listText":"<a href=\"https://laohu8.com/S/NGD\">$New(NGD)$</a>Should stay above the&nbsp;support (blue line). Then we will see uptrend to retest the resistance line.&nbsp;DYOR","text":"$New(NGD)$Should stay above the support (blue line). Then we will see uptrend to retest the resistance line. DYOR","images":[{"img":"https://static.tigerbbs.com/6dfa9ac22e0e1960304b3a27a3caa1e8","width":"1125","height":"2671"}],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/825253254","isVote":1,"tweetType":1,"viewCount":887,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":1,"langContent":"CN","totalScore":0}],"lives":[]}