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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
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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\">\nDBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\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\">2021-12-21 22:22</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<p>After reviewing the FDA's information requests and considering all other options, <b>DBV Technologies</b> has decided not to pursue the sequential approach to develop Viaskin Peanut (allergen uptake/transport study before STAMP).</p>\n<ul>\n <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>\n <li>Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.</li>\n <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>\n <li>The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.</li>\n <li>DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.</li>\n <li>At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).</li>\n <li><b>Price Action:</b> DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.</li>\n</ul>\n\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 Tuesday.","news_type":1},"isVote":1,"tweetType":1,"viewCount":654,"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/691011206"}
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