DNDN-The issue regarding the missed primary endpoint in 9901 is misleading, IMO. The biostatisticians allocated the 0.05 alpha to the progression endpoint, and stated that any other endpoints beyond progression would merely be exploratory if alpha were missed. However, the 0.05 figure is an arbitrary cutoff. The FDA kept the p value for progression at the original unblinded 0.085, but the correct p value was actually 0.052 due to the CRO's mistakes in putting the wrong figures in the wrong columns and other blunders. So, depending on which analysis to use, the likelihood of Provenge's benefit in delaying progression being due to chance would only be 5.2% to 8.5%. The survival p value was 0.01, so there does appear to be a correlation here.
Should we keep this treatment away from patients because its benefit in delaying progression is only 94.8% likely to be due to the treatment instead of the required 95%, all the while knowing that the odds of the survival benefit being due to the treatment and not random chance are 99%...and it has an extremely mild toxicity profile?
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