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Portola (PTLA) Expects FDA Decision on Andexxa (Andexanet Alfa) on May 4, 2018

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Additional Information

Additional Relevant Details Initially expected by the end of 2017, the BLA has been resubmitted with a PDUFA date of February 2, 2018
Additional Relevant Details Update on Dec 24 2017: Date extension from Feb 2 2018 to May 4 2018.
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Catalyst Date
Occurred on:
May 03, 2018
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Related Keywords Fda Decision, Andexxa, Serious Uncontrolled Bleeding Event, Urgent, Emergent Surgery, Andexanet Alfa