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2021-12-20

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PolarityTE Shares Advance 10% After Submitting Response to FDA

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

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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\">\nPolarityTE Shares Advance 10% After Submitting Response to FDA \n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-12-20 21:46 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.marketwatch.com/story/polarityte-shares-advance-10-after-submitting-response-to-fda-271640007099?mod=newsviewer_click><strong>Marketwatch</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\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 ...</p>\n\n<a href=\"https://www.marketwatch.com/story/polarityte-shares-advance-10-after-submitting-response-to-fda-271640007099?mod=newsviewer_click\">Web Link</a>\n\n</div>\n\n\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":1492,"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}