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Provenge in 2008 hinges on interim data

Executive Summary

FDA will accept interim data from ongoing IMPACT study as a basis for resubmission of Dendreon's prostate cancer vaccine Provenge (sipuleucel-T). Data from the Phase III study are expected in mid-to-late 2008, CEO Mitchell Gold says during the Bank of America Health Care conference May 31. If the interim analysis does not show improved patient survival, the review would be further delayed until at least 2010, when final data are anticipated. FDA issued a "complete response" letter seeking additional efficacy data on the prostate cancer treatment May 8 (1"The Pink Sheet" May 14, 2007, In Brief)...

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