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EnteroMedics Inc. Message Board

  • dctrig dctrig Jul 26, 2013 12:06 PM Flag

    The Reason FDA Wants Advisory Panel Vote

    FYI, an SPA is not engraved in stone. Encysive's Thelin met their SPA and was rejected multiple times by the FDA(Safety issues later caused its Euro withdrawal). VBLOC demonstrated superiority to the control group but not super superiority(whatever that is); however, the FDA is impressed with VBLOC's ability to lower blood pressureand its positive effect on diabetes and even some strokes and cancers. The FDA wants the advisory panel to give them cover to approve VBLOC.

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