Cytodyn Inc (CYDY): The review cycle does not “typically” st...

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Re: Amatuer17 post# 38083

Monday, 03/04/2019 9:59:19 AM

Monday, March 04, 2019 9:59:19 AM

The review cycle does not “typically” start. Is this PR implying that the FDA will actually begin reviewing portions of the BLA ahead of time? I don’t know. That would be beneficial though. Even if the official PDUFA clock doesn’t start until final acceptance of the full BLA, reviewing major portions of the work ahead of time could expedite things. The FDA has been known - recently - to approve drugs months ahead of PDUFA dates in select cases.

Regardless, I think that we can all agree that NP should hire Bored Lawyer to write the PR’s so words would have meanings again. I tire of parsing the company’s choice of words on every single thing thanks to careless or imprecise language.

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