This is the text of Howard Scher M.D.’s letter to FDA about the March 29th advisory committee hearing on Dendreon’s vaccine Sipuleucel-T (Provenge):

I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall short of the regulatory requirements; an inadequate statistical construct to determine definitive benefit; incomplete data on product safety; and what appear to be different criteria for approval by two Advisory Committees to the Agency.

A week before the FDA advisory committee meeting on Dendreon’s Provenge, investment analyst Adam Feuerstein predicted that if Provenge is approved it could generate over $100 million in sales in 2008. Feuerstein’s estimate is based on a projected price of $30,000 per year per course of the vaccine. His model assumes increasing numbers of men living with (and dying of) metastatic androgen independent refractory prostate cancer (AIPrC) over the next decade.