Replies to post #3631 on AEterna Zentaris Inc. (AEZS)

[at14tao]

Let me rephrase that, chance of approval on FDA's 1st review cycle of NDA, 44%. On time or not. 75% eventually got approval.
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/05/gao-report-says-that-fda-has-met-most-pdufa-performance-goals-agency-plans-to-take-steps-to-address-.html