Demonsoh
2021-11-24
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FDA Denies Breakthrough Tag For NRx Pharma's COVID-19 Candidate
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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\">\nFDA Denies Breakthrough Tag For NRx Pharma's COVID-19 Candidate\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-11-24 22:07 GMT+8 <a href=https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Relief Therapeutics Holding SA's collaborating partner NRx Pharmaceuticals Inc has announced that the FDA has denied Breakthrough Therapy Designation for aviptadil.\n\nNRx noted that though the ...</p>\n\n<a href=\"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NRXP":"NRX Pharmaceuticals Inc.","RLFTF":"RELIEF THERAPEUTICS HLDG AG"},"source_url":"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1167653292","content_text":"Relief Therapeutics Holding SA's collaborating partner NRx Pharmaceuticals Inc has announced that the FDA has denied Breakthrough Therapy Designation for aviptadil.\n\nNRx noted that though the designation is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel.\nAdditionally, according to the CEO Update, the FDA has already granted priority and rolling review as part of the Fast Track Designation awarded in July 2020.\nTherefore, the denial does not impede NRx's ability to seek drug approval.\nRelief's lead drug candidate, RLF-100 (aviptadil), is a synthetic form of Vasoactive Intestinal Peptide (VIP).\nIt is in late-stage clinical testing in the U.S. for respiratory deficiency due to COVID-19..\nPrice Action: NRXP shares closed 5.56% lower at $4.25 during after-hours trading on Tuesday.","news_type":1},"isVote":1,"tweetType":1,"viewCount":735,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":10,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/874873453"}
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