Provenge set back until 2008

Executive Summary

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)...