BR64 schreef op 19 juni 2013 16:18:
The FDA indicated that as part of its review it plans to present the BLA to the Blood Products Advisory Committee. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, Santarus and Pharming expect the FDA will complete its review or otherwise respond to the RUCONEST BLA by April 16, 2014.
dit staat letterlijk in het persbericht. wat je daar stelt is goed. het zou inderdaad minder dan 10 maanden kunnen duren.