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Re: dr_lowenstein post# 31886

Tuesday, 07/28/2015 9:30:24 PM

Tuesday, July 28, 2015 9:30:24 PM

Post# of 48316
You should look up the term "accelerated approval" to get your examples. It is up to you to do your own DD as you have reminded us of so often. In general a P3 is still required to confirm results, but that is only AFTER approval and is done to confirm results/safety. Spectacular is all in the eyes of the beholder, or in this case whoever might offer a buyout. I will leave it up to you to define in your mind what spectacular means.