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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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Provenge set back until 2008

Approval of Dendreon's therapeutic cancer vaccine Provenge (sipuleucel-T) could be based on an interim analysis of an ongoing Phase III study called IMPACT, expected in 2008, CEO Mitchell Gold says during a first quarter conference call May 11. The firm believes it has the necessary cash balance to fund the company through the interim analysis, but would likely seek refinancing prior to resubmitting Provenge to FDA. The update comes after Dendreon was dealt a blow by FDA when the agency issued a "complete response" letter seeking additional efficacy data on the prostate cancer treatment May 8. FDA's action departs from the recommendation by the agency's Cellular, Tissue and Gene Therapies Advisory Committee, which had issued a favorable recommendation on efficacy (1"The Pink Sheet" April 9, 2007, p. 7)...

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