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DewDiligence

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DewDiligence

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Re: DewDiligence post# 199794

Thursday, 08/18/2016 9:23:11 AM

Thursday, August 18, 2016 9:23:11 AM

Post# of 251972
PTLA -20%/PM on CRL for AndexXa (an antidote for oral FXa inhibitors f/k/a Andexanet alfa):

http://finance.yahoo.com/news/portola-pharmaceuticals-receives-complete-response-025707586.html

In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalize its review of the clinical amendments to Portola’s post-marketing commitments that recently were submitted.

Inasmuch as PTLA was down sharply yesterday, news of this CRL evidently leaked.

I'm skeptical of the market opportunity for this drug (#msg-120615780).

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

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