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FRX Message Board

  • stock.addicted stock.addicted Apr 7, 2010 4:11 PM Flag


    Just looked at the briefing doc.
    It looks that FRX changed indication from 'maintenance treatment of COPD' to 'reduction of exacerbations of COPD' in rush on 1/29/10. Obviously, FDA reviewers didn't get enough time to review based on the changed indication and ask the advisor committee to focus on the previous indication submbited by Nycomed. This is problem one.
    Problem two: the efficacy is too modest. FEV1 change from Daxas is only about 40-50, not clinically significant. Other existing treatments can reach up to 100.
    Problem 3: Causing cancer
    Problem 4: suicide
    problem 5: study endpoint is not consistent. some study used SGRQ, some didn't.
    Good luck