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OncoGenex Pharmaceuticals, Inc. Message Board

  • boxcarlong boxcarlong Mar 14, 2013 11:28 AM Flag

    House keeping Issue

    Comment from Seeking Alpo Dated 3/13/13 Titled:

    Synergy Trial is The Major Catalyst In Sight

    Last paragraph: The FDA has stated that the Synergy trial alone would be sufficient for approval.

    Is this fact or fiction? TIA

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    • Fact. The FDA often requires positive results in at least two trials (I've never known whether that was a rule or an informal policy that isn't always followed). But Cormack has said on several calls including the recent ones that the FDA has informed OGXI that success in SYNERGY alone would suffice because of the positive (though not quite statistically significant) results in the randomized P2 prostate trial for 011.

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