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. ...continue reading "Scher to FDA about Provenge hearing"