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2021-12-21

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DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low<blockquote>DBV Technologies 将对花生过敏贴片进行新的关键试验，股价跌至 52 周低点</blockquote>

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thanks","highlighted":1,"essential":1,"paper":1,"likeSize":7,"commentSize":1,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/691035153","repostId":1120012619,"repostType":4,"repost":{"id":"1120012619","kind":"news","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":1640096524,"share":"https://www.laohu8.com/m/news/1120012619?lang=zh_CN&edition=full","pubTime":"2021-12-21 22:22","market":"us","language":"en","title":"DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low<blockquote>DBV Technologies 将对花生过敏贴片进行新的关键试验，股价跌至 52 周低点</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1120012619","media":"Benzinga","summary":"After reviewing the FDA's information requests and considering all other options, DBV Technologies h","content":"<p>After reviewing the FDA's information requests and considering all other options,&nbsp;<b>DBV Technologies</b>&nbsp;has&nbsp;decided not to pursue the sequential approach&nbsp;to develop Viaskin Peanut (allergen uptake/transport study before STAMP).</p><p><blockquote>在审查了FDA的信息请求并考虑了所有其他选项后，<b>DBV技术</b>已决定不采用顺序方法开发Viaskin花生（STAMP之前的过敏原摄取/运输研究）。</blockquote></p><p> <ul>  <li>DBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.</li>  <li>Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.</li>  <li>The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.</li>  <li>The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.</li>  <li>DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.</li>  <li>At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).</li>  <li><b>Price Action:</b>&nbsp;DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.</li> </ul></p><p><blockquote><ul><li>DBV估计，在启动STAMP、6个月的安全性和依从性研究之前，注意FDA新提出的顺序方法将需要至少五轮需要FDA一致性的交换。</li><li>相反，DBV将在目标患者人群中的儿童中启动一项改良Viaskin花生贴片的3期研究。</li><li>该研究将采用改良的Viaskin花生（mVP）贴片，其形状为圆形，比当前的Viaskin花生（cVP）贴片大约50%。</li><li>该公司正在最终确定该方案，并预计在 2022 年 2 月底之前向 FDA 提交该方案。</li><li>DBV Technologies 还决定撤回欧洲营销应用 Viaskin Peanut。</li><li>撤回时，该产品正在接受 EMA 人用药品委员会 (CHMP) 的审查。</li><li><b>价格行为：</b>周二最后一次检查时，DBVT 股价在盘前交易中下跌 25.90%，至 2 美元。</li></ul></blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta 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Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low<blockquote>DBV Technologies 将对花生过敏贴片进行新的关键试验，股价跌至 52 周低点</blockquote>\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\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 smaller\">2021-12-21 22:22</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<p>After reviewing the FDA's information requests and considering all other options,&nbsp;<b>DBV Technologies</b>&nbsp;has&nbsp;decided not to pursue the sequential approach&nbsp;to develop Viaskin Peanut (allergen uptake/transport study before STAMP).</p><p><blockquote>在审查了FDA的信息请求并考虑了所有其他选项后，<b>DBV技术</b>已决定不采用顺序方法开发Viaskin花生（STAMP之前的过敏原摄取/运输研究）。</blockquote></p><p> <ul>  <li>DBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.</li>  <li>Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.</li>  <li>The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.</li>  <li>The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.</li>  <li>DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.</li>  <li>At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).</li>  <li><b>Price Action:</b>&nbsp;DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.</li> </ul></p><p><blockquote><ul><li>DBV估计，在启动STAMP、6个月的安全性和依从性研究之前，注意FDA新提出的顺序方法将需要至少五轮需要FDA一致性的交换。</li><li>相反，DBV将在目标患者人群中的儿童中启动一项改良Viaskin花生贴片的3期研究。</li><li>该研究将采用改良的Viaskin花生（mVP）贴片，其形状为圆形，比当前的Viaskin花生（cVP）贴片大约50%。</li><li>该公司正在最终确定该方案，并预计在 2022 年 2 月底之前向 FDA 提交该方案。</li><li>DBV Technologies 还决定撤回欧洲营销应用 Viaskin Peanut。</li><li>撤回时，该产品正在接受 EMA 人用药品委员会 (CHMP) 的审查。</li><li><b>价格行为：</b>周二最后一次检查时，DBVT 股价在盘前交易中下跌 25.90%，至 2 美元。</li></ul></blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"DBVT":"DBV Technologies S.A."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1120012619","content_text":"After reviewing the FDA's information requests and considering all other options, DBV Technologies has decided not to pursue the sequential approach to develop Viaskin Peanut (allergen uptake/transport study before STAMP).\n\nDBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.\nInstead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.\nThe study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.\nThe Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.\nDBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.\nAt the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).\nPrice Action: DBVT shares are down 25.90% at $2 during the premarket session on the last check 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