Thursday, May 29, 2014 7:22:40 PM
After thinking and thinking and thinking
Even if the drug cured 100% of the time and also cured ED and caused the patient to crap gold bricks
Even the FDA probably decided that an approval on that type of study without PIB data would set a precedent and give them all kinds of grief down the road from other drug btd applications
I think the FDA probably thought in the type c meeting that skipping that data was no biggie
But more conservative heads were thinking down the road at the final meeting about the fallout
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