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ghmm

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ghmm

Re: iwfal post# 44998

Saturday, 04/14/2007 6:52:46 PM

Saturday, April 14, 2007 6:52:46 PM

Post# of 252507
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.
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