FDA has agreed to an amended Special Protocol Assessment for the Phase 3 IMPACT clinical trial of PROVENGE. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application for licensure of PROVENGE.
However, a real result has yet to materialize and change to the FDA position, which is not contained in this news item. While it may show some level of advancement, it may be a good idea to watch for further results.
I like going long the May 40 Calls and May 30 Puts. This stock will react to the FDA action on Provenge in May.
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer.