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DewDiligence

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DewDiligence

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Re: mcbio post# 180898

Friday, 08/01/2014 1:58:30 PM

Friday, August 01, 2014 1:58:30 PM

Post# of 252683

There is usually an end-of-Phase-2 meeting with the FDA…to get some feedback on what would constitute a successful Phase 3 study design and result. But, I don't think the FDA formally has to approve a Phase 3 start.

Correct, unless the FDA thinks the proposed phase-3 program has unacceptable safety risks.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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