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2021-11-24

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FDA Denies Breakthrough Tag For NRx Pharma's COVID-19 Candidate<blockquote>FDA否认NRx Pharma的COVID-19候选药物的突破性标签</blockquote>

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NRx noted that though the ...</p><p><blockquote><div>Relief Therapeutics Holding SA的合作伙伴NRx Pharmaceuticals Inc宣布，FDA已拒绝阿维他地尔的突破性疗法认定。NRx指出，尽管...</div></blockquote></p><p>  <a href=\"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate\">网页链接</a>  </div> </p><p><blockquote><a href=\"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate\">网页连接</a></blockquote></p><p></p>","source":"lsy1606299360108","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>FDA Denies Breakthrough Tag For NRx Pharma's COVID-19 Candidate<blockquote>FDA否认NRx Pharma的COVID-19候选药物的突破性标签</blockquote></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: 12.5px; color: #7E829C; margin: 0;}\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<blockquote>FDA否认NRx Pharma的COVID-19候选药物的突破性标签</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Benzinga</strong><span class=\"h-time small\">2021-11-24 22:07</span>\n</p>\n</h4>\n</header>\n<article>\n<p><div> Relief Therapeutics Holding SA's collaborating partner NRx Pharmaceuticals Inc has announced that the FDA has denied Breakthrough Therapy Designation for aviptadil.  NRx noted that though the ...</p><p><blockquote><div>Relief Therapeutics Holding SA的合作伙伴NRx Pharmaceuticals Inc宣布，FDA已拒绝阿维他地尔的突破性疗法认定。NRx指出，尽管...</div></blockquote></p><p>  <a href=\"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate\">网页链接</a>  </div> </p><p><blockquote><a href=\"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate\">网页连接</a></blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://www.benzinga.com/general/biotech/21/11/24269339/fda-denies-breakthrough-tag-for-nrx-pharmas-covid-19-candidate\">Benzinga</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\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,"symbols_score_info":{"NRXP":0.9,"RLFTF":0.9}},"isVote":1,"tweetType":1,"viewCount":817,"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":6,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/874873612"}