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DewDiligence

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DewDiligence

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Re: DewDiligence post# 198389

Wednesday, 02/17/2016 7:28:21 PM

Wednesday, February 17, 2016 7:28:21 PM

Post# of 257300
PTLA’s PDUFA date for Andexanet Alfa is 8/17/16 (with priority review):

http://finance.yahoo.com/news/portola-pharmaceuticals-announces-biologics-license-224217932.html

This BLA seeks FDA accelerated approval based on the surrogate endpoint of FXa reversal. A single-arm phase-4 trial is already in progress to show that Andexanet Alfa can safely restore hemostasis in patients with major, including life-threatening, bleeding (#msg-109888826).

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

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