a****g
发帖数: 8131 | 1 基本原则
1. 提出pick，给出fa，ta信息;提出问题讨论
2. 尽量减少无必要的灌纯水活动
3. 建议修改自己的原贴减少帖子数目；而且便于大家跟踪
4. 我会每隔一段时间做个同主题，加上日期以便大家查询 | a****g
发帖数: 8131 | 2 life is up and ilmn is down
anyone familiar with the market size? | v**********m
发帖数: 5516 | 3 FDA Accepts Resubmission Of Arena Pharmaceuticals And Eisai Inc's Lorcaserin
New Drug Application
8:01am EST
Arena Pharmaceuticals and Eisai Inc. announced that the US Food and Drug
Administration (FDA) has accepted for filing and review Arena's resubmission
of the New Drug Application (NDA) for lorcaserin. The FDA considers the
resubmission a complete, class 2 response, and assigned a new Prescription
Drug User Fee Act (PDUFA) target date of June 27, 2012. Lorcaserin is
intended for weight management, including weight loss and maintenance of
weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or
patients who are overweight (BMI >27) and have at least one weight-related
co-morbid condition. Arena submitted the original NDA for lorcaserin in
December 2009, and the FDA issued a Complete Response Letter (CRL) in
October 2010. Arena submitted a response to the lorcaserin CRL in December
2011. |
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