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Wednesday, October 10, 2007 1:36:28 PM
This is a silly exercise in futility. Kind of like arguing if Ali was a better athlete than Tiger Woods. Fun, maybe but is there a definitve answer- no. Provenge is a completely different drug, in a completely different disease state and no scientist would rely on such a sophomoric analysis. Fun, but use it to make investment decisions- risky business.
Furthermore, the Dor side of the chart is inaccurate and misleading.
It ignores the FDA medical reviewer's comments: Reviewer comment: Even after failure of the primary endpoint, the applicant conducted multiple analyses on many pre-specified and non-pre-specified endpoints. These are considered as exploratory or hypothesis generating
It ignores the FDA statistician's comments:
Multiplicity
• Multiple analyses on multiple pre-specified and non-specified endpoints for study ENT 00-02, study 875 and both studies combined were conducted. •Once the study failed on the primary endpoint, any further analyses are exploratory and statistical significance cannot be determined.
Fun to look at, yes, meaningful from a statistical, medical or regulatory point of view, no. Dont be fooled.
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