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2021-12-20

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PolarityTE Shares Advance 10% After Submitting Response to FDA<blockquote>PolarityTE向FDA提交回应后股价上涨10%</blockquote>

PolarityTE Inc.'s shares jumped early Monday after the biotechnology company said it submitted a com

PolarityTE Shares Advance 10% After Submitting Response to FDA<blockquote>PolarityTE向FDA提交回应后股价上涨10%</blockquote>

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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\">\nPolarityTE Shares Advance 10% After Submitting Response to FDA<blockquote>PolarityTE向FDA提交回应后股价上涨10%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Marketwatch</strong><span class=\"h-time small\">2021-12-20 21:46</span>\n</p>\n</h4>\n</header>\n<article>\n<p>PolarityTE Inc.'s shares jumped early Monday after the biotechnology company said it submitted a complete response to the U.S. Food and Drug Administration's clinical hold on an investigational new drug application for SkinTE with a proposed indication for chronic cutaneous ulcers.</p><p><blockquote>PolarityTE Inc.表示已向美国提交完整回应后，该公司股价周一早盘上涨。美国食品药品监督管理局临床搁置了SkinTE的一项研究性新药申请，该申请的拟议适应症为慢性皮肤溃疡。</blockquote></p><p> The primary hold correspondence from the FDA related to certain chemistry, manufacturing and control items, including the assay to demonstrate the potency of SkinTE, the company said.</p><p><blockquote>该公司表示，FDA的主要持有信件涉及某些化学、制造和控制项目，包括证明SkinTE效力的检测。</blockquote></p><p> In premarket trading, the stock was 10% higher after ending Friday at 39 cents, down more than 40% since the end of last year.</p><p><blockquote>在盘前交易中，该股周五收于39美分后上涨10%，自去年年底以来下跌了40%以上。</blockquote></p><p> PolarityTE said that under FDA's standard practices and regulations, if the regulator agrees that the company's response is complete then a decision should be communicated within 30 days, subject to potential delays or other unforeseen circumstances.</p><p><blockquote>PolarityTE表示，根据FDA的标准实践和法规，如果监管机构同意公司的响应已完成，则应在30天内传达决定，但可能会出现延误或其他不可预见的情况。</blockquote></p><p> \"We believe that our response is robust and compelling in terms of addressing the issues raised by the FDA,\" Chief Executive Officer and President Richard Hague said.</p><p><blockquote>首席执行官兼总裁理查德·黑格(Richard Hague)表示：“我们相信，在解决FDA提出的问题方面，我们的应对措施是强有力且令人信服的。”</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://www.marketwatch.com/story/polarityte-shares-advance-10-after-submitting-response-to-fda-271640007099?mod=newsviewer_click\">Marketwatch</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":{"PTE":"PolarityTE, Inc."},"source_url":"https://www.marketwatch.com/story/polarityte-shares-advance-10-after-submitting-response-to-fda-271640007099?mod=newsviewer_click","is_english":true,"share_image_url":"https://static.laohu8.com/599a65733b8245fcf7868668ef9ad712","article_id":"1102069847","content_text":"PolarityTE Inc.'s shares jumped early Monday after the biotechnology company said it submitted a complete response to the U.S. Food and Drug Administration's clinical hold on an investigational new drug application for SkinTE with a proposed indication for chronic cutaneous ulcers.\nThe primary hold correspondence from the FDA related to certain chemistry, manufacturing and control items, including the assay to demonstrate the potency of SkinTE, the company said.\nIn premarket trading, the stock was 10% higher after ending Friday at 39 cents, down more than 40% since the end of last year.\nPolarityTE said that under FDA's standard practices and regulations, if the regulator agrees that the company's response is complete then a decision should be communicated within 30 days, subject to potential delays or other unforeseen circumstances.\n\"We believe that our response is robust and compelling in terms of addressing the issues raised by the FDA,\" Chief Executive Officer and President Richard Hague said.","news_type":1,"symbols_score_info":{"PTE":0.9}},"isVote":1,"tweetType":1,"viewCount":2118,"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":[],"hasMoreComment":false,"orderType":2}