Replies to post #206056 on Biotech Values

[DewDiligence]

PTLA—Betrixaban PDUFA date is 6/24/17 (with priority review):

http://finance.yahoo.com/news/portola-pharmaceuticals-announces-fda-accepts-191225419.html

Also, the EMA “validated” the Betrixaban MAA submission, allow the formal review to begin.

I’m skeptical of the approval chances, as previously noted on this board.

[DewDiligence]

FDA approves Bevyxxa* (betrixaban) for VTE prevention in immobilized hospital patients—this is the label:

https://t.co/ekUfLbKCtA

I was skeptical of this program for various reasons, including the fact that the single phase-3 trial had a p-value >0.05 in a situation where p<0.01 would normally be required.

It looks like the FDA really has loosened up to some degree.

*Clever (and expected) for “Xa” to be in the name insofar as Bevyxxa is a Factor-Xa inhibitor.