It's not some flood gate being held back at that stage - phase 3 is simply where the majority of pharmaceutical companies fail.
Um- no Doc- lets look at some numbers - Oncology for example.
Success rate for trials from Phase 1 to approval is around 3%, then it doubles from Phase 2 and then guess what happens- it leaps El Doccy Doc- Phase 3 over 33 % chance of approval- which sort of disagrees with your intimate knowledge of pharmaceutical trials.
And just cause I can't help myself - if you get past the Phase 3 and submit - it leaps again El Doccy Doc- now a whopping 80% plus!!!!!!!!!!!!!!!!
I wonder what the odds are with a positive Adcom vote- a spiffy manufacturing inspection, a withdrawn CRL and an ex FDA department chief holding your hand??
Reg
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