Dendreon receives Complete Response Letter from FDA for Provenge Biologics License Application (17.74 ) : Co announces that it received a Complete Response Letter, known as an "approvable" letter, on May 8, 2007 from the FDA regarding its Biologics License Application for PROVENGE for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer. The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The co is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls section of the BLA, which the co believes it can supply to the FDA in a timely manner. "Given our strong belief in the survival benefit and safety profile of PROVENGE, coupled with the positive outcome of the Advisory Committee meeting, we are disappointed that this decision will cause a delay in the availability of PROVENGE for patients who suffer from advanced prostate cancer... We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner to bring PROVENGE to patients with advanced prostate cancer who currently have few appealing treatment options."