Evergreen未然
2019-10-31
小药股真癫。先是FDA发文件说了一大堆负面：肥胖用户、效果和安全的平衡、剂量问题…市场疯了，立刻70%跳楼！结果Adcom 14:1 投票通过。市场又疯了……还得加倍跳回来。11月得看看FDA要怎么演了…… 把研究做扎实，相信自己的判断，有时候就是这么难。但投资要想获利，有时候就是这么反人性…… 恭喜各位坚持价值判断的投资人。
@科迪勒拉Biotech
@Evergreen未然：
AG200-15/Twirla 第3次冲击PDUFA能否获批？
免责声明：上述内容仅代表发帖人个人观点，不构成本平台的任何投资建议。
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Evergreen未然
2019-11-07
Evergreen未然
终于在3上全部了结。 既然已经安全的吃了最甜的甘蔗，为啥不完最好的一段，就换下一根呢？
什么也没有了～
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src=\"https://static.tigerbbs.com/b2cbff159e00b09d474f4b0a1f6cfed6\"></p><p>Twirla（左炔诺孕酮/炔雌醇经皮系统）/AG200-15</p><p>是一种低剂量、每周一次的联合激素避孕贴片，含有雌激素的有效成分炔雌醇（ee）和孕激素的左炔诺孕酮（lng）。Twirla的设计是每周使用一次，持续三周，然后一周不使用补片。</p><p>既往递交史与问题</p><p>2013年CRL：需要额外的临床数据</p><p>2017年CRL：需要额外的临床数据，已经纳入了phase 3 SECURE的研究数据。FDA认为提供数据不足以支撑药物获批，需要额外提供研究证明或者重新设计药物（“FDA determines that our data do not support approval of the Twirla NDA and requires us to conduct additional studies or reformulate Twirla to a”）<img src=\"https://static.tigerbbs.com/a6931049ab9e9ddab5ea28734d5e325d\"></p><p><img src=\"https://static.tigerbbs.com/8668e19378a04665d7c900cbf09a4a0c\"></p><p>FDA认为存在的问题：</p><p>quality control adhesion test methods for the Twirla manufacturing process,</p><p>l observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, </p><p>l questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results.</p><p>因此新的NDA需要解决两个问题</p><p>（1） 有无新的设计，消除FDA对药物粘附的顾虑？</p><p>（2） 新设计的药物的有效性（与常规药物的生物等效性）和安全性</p><p><strong>没有重新设计药物</strong></p><p><strong>进行了一项I期临床研究比较AG200-15和Xulane的粘附效果，非劣性设计，认为AG200-15的粘附效果更好，非劣于Xulane</strong></p><p>Evergreen Hall认为基于该结果的确能够说明AG200-15的粘附不是问题。</p><p><img src=\"https://static.tigerbbs.com/ae4703159e084f9b4cc64c0caf48fa37\"></p><p><img src=\"https://static.tigerbbs.com/654cebd1981696a828e992e5d77e2ae8\"></p><h2><strong>因此，Evergreen Hall 认为此次Twirla 第3次冲击PDUFA 大概率可以获批！</strong></h2><p>让我们拭目以待吧！</p></body></html>","htmlText":"<html><head></head><body><h2><a target=\"_blank\" href=\"https://laohu8.com/S/AGRX\">$Agile Therapeutics, Inc.(AGRX)$</a> </h2><p><img src=\"https://static.tigerbbs.com/b2cbff159e00b09d474f4b0a1f6cfed6\"></p><p>Twirla（左炔诺孕酮/炔雌醇经皮系统）/AG200-15</p><p>是一种低剂量、每周一次的联合激素避孕贴片，含有雌激素的有效成分炔雌醇（ee）和孕激素的左炔诺孕酮（lng）。Twirla的设计是每周使用一次，持续三周，然后一周不使用补片。</p><p>既往递交史与问题</p><p>2013年CRL：需要额外的临床数据</p><p>2017年CRL：需要额外的临床数据，已经纳入了phase 3 SECURE的研究数据。FDA认为提供数据不足以支撑药物获批，需要额外提供研究证明或者重新设计药物（“FDA determines that our data do not support approval of the Twirla NDA and requires us to conduct additional studies or reformulate Twirla to a”）<img src=\"https://static.tigerbbs.com/a6931049ab9e9ddab5ea28734d5e325d\"></p><p><img src=\"https://static.tigerbbs.com/8668e19378a04665d7c900cbf09a4a0c\"></p><p>FDA认为存在的问题：</p><p>quality control adhesion test methods for the Twirla manufacturing process,</p><p>l observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, </p><p>l questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results.</p><p>因此新的NDA需要解决两个问题</p><p>（1） 有无新的设计，消除FDA对药物粘附的顾虑？</p><p>（2） 新设计的药物的有效性（与常规药物的生物等效性）和安全性</p><p><strong>没有重新设计药物</strong></p><p><strong>进行了一项I期临床研究比较AG200-15和Xulane的粘附效果，非劣性设计，认为AG200-15的粘附效果更好，非劣于Xulane</strong></p><p>Evergreen Hall认为基于该结果的确能够说明AG200-15的粘附不是问题。</p><p><img src=\"https://static.tigerbbs.com/ae4703159e084f9b4cc64c0caf48fa37\"></p><p><img src=\"https://static.tigerbbs.com/654cebd1981696a828e992e5d77e2ae8\"></p><h2><strong>因此，Evergreen Hall 认为此次Twirla 第3次冲击PDUFA 大概率可以获批！</strong></h2><p>让我们拭目以待吧！</p></body></html>","text":"$Agile Therapeutics, Inc.(AGRX)$ Twirla（左炔诺孕酮/炔雌醇经皮系统）/AG200-15 是一种低剂量、每周一次的联合激素避孕贴片，含有雌激素的有效成分炔雌醇（ee）和孕激素的左炔诺孕酮（lng）。Twirla的设计是每周使用一次，持续三周，然后一周不使用补片。 既往递交史与问题 2013年CRL：需要额外的临床数据 2017年CRL：需要额外的临床数据，已经纳入了phase 3 SECURE的研究数据。FDA认为提供数据不足以支撑药物获批，需要额外提供研究证明或者重新设计药物（“FDA determines that our data do not support approval of the Twirla NDA and requires us to conduct additional studies or reformulate Twirla to a”） FDA认为存在的问题： quality control adhesion test methods for the Twirla manufacturing process, l observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, l questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results. 因此新的NDA需要解决两个问题 （1） 有无新的设计，消除FDA对药物粘附的顾虑？ （2） 新设计的药物的有效性（与常规药物的生物等效性）和安全性 没有重新设计药物 进行了一项I期临床研究比较AG200-15和Xulane的粘附效果，非劣性设计，认为AG200-15的粘附效果更好，非劣于Xulane Evergreen Hall认为基于该结果的确能够说明AG200-15的粘附不是问题。 因此，Evergreen Hall 认为此次Twirla 第3次冲击PDUFA 大概率可以获批！ 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既然已经安全的吃了最甜的甘蔗，为啥不完最好的一段，就换下一根呢？","text":"终于在3上全部了结。 既然已经安全的吃了最甜的甘蔗，为啥不完最好的一段，就换下一根呢？","html":"终于在3上全部了结。 既然已经安全的吃了最甜的甘蔗，为啥不完最好的一段，就换下一根呢？","likeSize":0,"commentSize":0,"subComments":[],"verified":10,"allocateAmount":0,"commentType":"valid","coins":0,"score":0,"disclaimerType":0}],"isCommentEnd":false,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/932061326"}
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