Replies to post #44998 on Biotech Values

[DewDiligence]

This ODAC reference document goes back to 1993:

http://www.fda.gov/cder/cancer/ODACframe.htm

With a little effort, you should be able to answer your question—at least for the period from 1993 to the present. Regards, Dew

[ghmm]

You mention drugs and ODAC so this doesn't apply but I remember a case with a medical device for depression (Medtronics) that received a positive recommendation and then was given a non-approvable (I believe). One of the most entertaining conference calls followed where the then CEO berated the FDA (he has since been forced to resign). I believe the device was later approved despite the non-approvable.