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Re: Adam_Feuerstein post# 53326

Wednesday, 02/10/2016 8:44:09 PM

Wednesday, February 10, 2016 8:44:09 PM

Post# of 700017
So, you're now focusing your bear thesis on PFS as the primary endpoint?
How do you suggest that the trial be designed around OS if the FDA required all patients who progress to cross over into an open label treatment arm?
Ultimately, the FDA (and no one else) will have to make the call on this - and they will certainly have to take into account their insistence on the crossover arm.
Puzdar had made it clear he is more flexible with these envelope-pushing trials.
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