Oh by the way, this website talked about POZN and ITMN option play.
baysky 发表于 2010-5-3 00:57
谢谢，BMY 昨天5月2号被FDA据了，又是老一套，延长点TRIAL时间，好进一步评估数据的有效性While no new clinical studies have been requested, the complete response letter requests the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The company will work with the FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the Phase 3 studies.
Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy (REMS).
这点还挺让人忧虑的，FDA最近好像改变审批条件了，凡是NDA和BLA都要经过REMS这个步骤好像就是从5月1号开始，明天ITMN不会被要求这个吧。哈。。。
The Biologics License Application for belatacept was accepted for filing and review by the FDA in September 2009. An FDA Advisory Committee panel met on March 1 of this year and voted 13-5 to recommend the approval of belatacept for the prophylaxis of rejection in kidney transplant recipients. The FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications.
这点也挺少见的。哈，也有点让人忧虑。。。
狗仔卡
发表于 2010-5-2 10:23 PM
