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Re: GD post# 216587

Tuesday, 02/20/2018 6:30:10 PM

Tuesday, February 20, 2018 6:30:10 PM

Post# of 251814
PTLA—(-10%/AH)—CHMP likely to reject Bextrixaban MAA:

https://finance.yahoo.com/news/portola-pharmaceuticals-announces-results-chmp-214747588.html

As a consolation prize, the CHMP will probably approve Andexanet Alfa (the FXa antidote).

As I've presviously posted on multiple occasions, PTLA was lucky to get FDA approval of Bevyxxa (the US brand name for betrixaban) based on a single phase-3 trial with a not-so-impressive p-value. The CHMP is quite reasonable to say no, IMO.

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