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MAP Pharmaceuticals, Inc. (MAPP) Message Board

  • twoonebecome twoonebecome Mar 22, 2012 12:12 PM Flag

    18 yrs pharma experience, this is a good bet

    I have 18 years experience in clinical trial set up for a CRO, and MAPP looks like a good bet. Points for approval:
    1.) Phase 3 trial was run under an SPA.
    2.) No adcom meeting called by FDA.
    3.) No need for another phase 3 study per FDA.
    4.) Patient total for all studies was 1000, with
    smoker, cardio risk, and asthmatics
    safety studied.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Never a sure thing with FDA.
      Depends on who is on the panel.
      I've seen sure bets fail because one or two people on the panel with personal financial or professional interests can focus on some arcane point and delay or deny approval.
      I wouldn't bet the farm here.
      But I agree, approval is highly likely.

 

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