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Jonathan Robinson

08/19/16 1:37 PM

#203652 RE: DewDiligence #203617

Idiotic things out there.
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DewDiligence

08/03/17 5:15 PM

#212846 RE: DewDiligence #203617

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).