Post by
zakmirza on Jan 20, 2016 10:34am
Some Facts
Historically FDA has approved a product 85% of the time when the Adcomm has been a yes. The FDA has rejected approval 86% of the time when the Adcomm is negative. Hmm! I feel approval is a toss up however. If Valstar with 10% success can get approved, MCNA with 25% success and significantly better safety and tolerability should be approved. Something, Adcomms this large are not common.
Comment by
zakmirza on Jan 20, 2016 10:47am
In the interest of accuracy, a slight correction. Between 2000-2010 the FDA approved NDA/BLA 88%(not 85%) when the panel has voted yes, coversely rejected it 86% of the time when the vote has been negative. Can we say approximately 15% chance of approval on Feb/27?
Comment by
Frogger2 on Jan 20, 2016 1:26pm
Look up joint committees (which is what TST was reviewed by), not the same statistics regarding approval.