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orphys

03/16/12 2:34 PM

#17227 RE: biomaven0 #17225

Harvey repeatedly stated on various conference calls that the trial was not powered to measure overall survival vs placebo. Its seems ridiculous that you reach an SPA with the FDA on how to structure the trial, meet the primary endpoint and then have the FDA rule against you because the trial didn't show efficacy against an endpoint the trial was not structured to demonstrate.