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DewDiligence

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DewDiligence

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Re: DewDiligence post# 231247

Monday, 10/19/2020 10:02:35 AM

Monday, October 19, 2020 10:02:35 AM

Post# of 252689
Opdivo/Cabometyx BLA/NDA for RCC combination therapy has 2/21/21 PDUFA (with FDA priority review):

https://www.businesswire.com/news/home/20201019005198/en

Since the treatment regimen, from the CHECKMATE-9ER study, is a combination of a biologic (Opdivo) and a small-molecule TKI (Cabometyx), the FDA is conducting separate but simultaneous reviews for each component, something you don’t often see.

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

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