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Thanks ACTcrazy :)

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H2R   Friday, 03/01/19 10:14:32 AM
Re: ACTcrazy post# 169
Post # of 196 
Thanks ACTcrazy :)

For now, a positive opinion from the CHMP!

https://seekingalpha.com/pr/17429923-european-chmp-adopts-positive-opinion-ondexxya-andexanet-alfa-portola-pharmaceuticals-factor

Quote:
SOUTH SAN FRANCISCO, Calif., March 01, 2019 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application (MAA) for Ondexxya™ (andexanet alfa). The Committee has recommended that the European Commission (EC) grant Ondexxya conditional approval for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban or rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.

The MAA will now be reviewed by the EC, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Liechtenstein and Iceland. If approved, Ondexxya would be the first and only specific reversal agent available in Europe to address life-threatening bleeding associated with the use of apixaban or rivaroxaban. The EC is expected to issue a decision in early May 2019.



Best of luck with your investments!

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