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