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Synta Pharmaceuticals Corp. Message Board

  • weichselbaum weichselbaum Jun 5, 2013 5:20 PM Flag

    Something to think about

    Had Galaxy 1 only included the population being included in the phase 3 trial, and had the relatively immature preliminary data not previously been disseminated, I believe the reaction to the recently announced interim data would have been quite positive. The only thing that matters at this point is the likelihood that the phase 3 trial will generate good results, i.e., overall survival advantage of approximately 4 months with a p value of .05 or less should be sufficient for FDA approval. It seems to me that the recently published data should provide a high degree of optimism for the phase 3 trial.

    Focus on the hazard ratio is misplaced because it does not reflect the magnitude of the benefit--how much longer will the patient who gets the combination live.

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