VIVUS, Inc. (VVUS) Provides Update on Timing of European Decision for Qnexa(R)
6/5/2012 10:12:51 AM
MOUNTAIN VIEW, Calif., June 5, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rescheduled the decision process on the Marketing Authorization Application (MAA) for Qnexa, an investigational drug for the treatment of obesity. In April, VIVUS submitted its response to the Day 180 List of Outstanding Issues from the CHMP, and was invited by the CHMP to participate in an oral hearing in order to provide additional explanations of the Day 180 response. An oral hearing is a customary part of the EMA approval process. VIVUS requested additional time to prepare for the oral hearing, and the CHMP has agreed to schedule the hearing in September 2012. The CHMP opinion on the Qnexa MAA is now expected following the September meeting.
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