Response About IMPACT Trial

A good question. In this kind of situation, the FDA would allow Dendreon to modify the trial design or protocol to eliminate the need for a placebo group. This is not a minor issue for the IMPACT trial of Prvenge, but it is not a show stopper. As you wrote, ethical issues preclude the use of a palcebo group when a treatment has been aprpoved for an illness. This issue came up during the FDA panel hearing and no one seemed concerned about this modificaiton to the trial. That being said, the changes would not be minor.