Curis expects that the FDA will notify Genentech whether its NDA submission has been accepted for filing within 60 days of submission, and if it is accepted, the agency will communicate to Genentech its targeted action date under the Prescription Drug User Fee Act (PDUFA) to complete its review of the NDA and potentially grant marketing approval of vismodegib.Roche has also indicated that the timing of a European regulatory submission is subject to its ongoing discussions with the European Medicines Agency (EMA). Curis is entitled to receive an additional milestone payment should such submission be made by Roche and subsequently accepted by the EMA, as well a milestone payment and royalties on future sales should vismodegib be approved by the EMA.
Curis Reports Third Quarter 2011 Financial Results
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