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Re: BaaBaa45 post# 8379

Wednesday, 06/12/2013 10:42:17 AM

Wednesday, June 12, 2013 10:42:17 AM

Post# of 429261
BaaBaa; It appears that you have misunderstood or misinterpreted things here. The ADvisory COMmittee is convened to assist the FDA in an area that they may or may not have particular expertise and the Adcom advises them in this area for approval or disapproval of a drug. The FDA does not have to accept this recommendation, also at this convened adcom meeting NCE is or is not discussed with reasons given if it is not. To the point of all this though is that NCE is not awarded prior to the Adcom meeting. Best wishes to us longs.
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