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DewDiligence

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DewDiligence

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Re: DewDiligence post# 203617

Thursday, 08/03/2017 5:15:20 PM

Thursday, August 03, 2017 5:15:20 PM

Post# of 257302
PTLA resubmits BLA for AndexXa (FXa antidote):

https://globenewswire.com/news-release/2017/08/03/1072296/0/en/Portola-Pharmaceuticals-Announces-Resubmission-of-Biologics-License-Application-for-AndexXa-Andexanet-Alfa.html

The resubmission includes supplemental information primarily related to manufacturing, as requested by the FDA in a complete response letter (CRL) issued to Portola in August 2016.

PTLA management seems to have matured since the embarrassing performance following the AndexXa CRL in 2016 (#msg-124624757).

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

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