Portola Pharmaceuticals Inc. is hoping to persuade FDA to approve its anticoagulant betrixaban based on the totality of data in its pivotal APEX study of high-risk, acute medically ill patients, even though the drug missed a key endpoint in the trial.
Will Portola’s Betrixaban Data Pass Muster With FDA?
Portola says that it does not expect it will need to do a second Phase III study to get FDA approval for betrixaban, after missing major endpoint in APEX, but analysts have doubts.
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