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Re: MateoPaisa post# 180116

Friday, 03/08/2019 11:46:22 PM

Friday, March 08, 2019 11:46:22 PM

Post# of 425256
Size of dossier won’t have an impact on being granted priority review. It might increase the rigor and duration of review, but the 6/10 month review window (depending on which we get) is plenty of time for them to go thru it.

Individual data listings and case report forms/narratives have to be generated + submitted for every patient/case, which is a huge amount of information (and work!) across those 8000 patients. That is monstrous...majority of Ph3 studies are a few thousand, max.

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