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semi_infinite

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semi_infinite

Re: DewDiligence post# 237288

Wednesday, 03/03/2021 1:59:30 PM

Wednesday, March 03, 2021 1:59:30 PM

Post# of 251500
FGEN - for practical purposes, the letter was equivalent to CRL with class 2 resubmission specified (Adcom) if analyst's estimate of require review timeline of 9 months is correct. At least that's the way institutional investors will read the situation. Are the FDA PhD's any stricter than PMDA/Shonin's PhD's, I doubt it. IMO Fgen crew could/should do better.
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