EMA will ignore Trumps FDA -greater Hemophilia need :
BA Analyst Meachum says we can still see EU
$BMRN
approval in 2020- EMA says 210 days til word on
$BMRN
Hemophilia approval - wow - even with clock stops - any day now : SAN RAFAEL, Calif., Dec. 23, 2019 /PRNewswire/ -- “BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. The MAA review will commence in January 2020 under accelerated assessment.
EMA granted access to its Priority Medicines (PRIME) regulatory initiative in 2017 and recently granted BioMarin's request for accelerated assessment of this MAA-This submission marks the first marketing application submission in Europe for a gene therapy product for any type of hemophilia.
Evaluating a MAA under the EMA centralized procedure can take up to 210 days.”
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