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AngeloFoca

08/18/17 2:55 PM

#29484 RE: fmgrana #29482

In the aggregate that means that about 10 percent of the time overall – at least using meetings since and including 2011 through 2016 FDA decides ultimately on a different course than was recommended by its advisers. So next time someone asks the question, you have an answer.



So there is certainly a chance... particularly since the FDA rep stated "assume those tests are already done".

I think there's more here than we are aware of... but I am not counting on it.

http://www.eyeonfda.com/eye_on_fda/2016/08/adcomm-recommendations-how-often-fda-does-not-follow-them.html