Thanks everyone...words cannot express how giddy I am right now.
IMO, the keys today were:
(1) the inexperience of several panel members on the concept of
voting yes or no to approve a treatment for a terminal condition. As a pretty good reader of people, it was apparent to me that these less experienced panel members would be more likely to be swayed by the public testimonials...
(2) and of course, Dr. Mule the chairman of the panel asking the FDA to clarify the efficacy question, and then holding a re-vote after the first three panel members voted extremely reluctantly NO. The three said that there was substantial evidence of efficacy, but not 100% conclusive. Dr. Mule got FDA's Dr. Witten to state that "substantial evidence of efficacy" means thumbs up. Game over!! Re-vote, and first guy still hems and haws but says yes, next five or six all say yes, and eventually we get 13-4.
(3) Also, the nonvoting industry representative did a MUCH better job of clarifying some of the stats data for the others. DNDN had NO REAL WORLD presenters behind the microphone, or at least nobody who could explain things in layman's terms to some of the advisory panel members. The nonvoting industry representative Dr. Gunter did a better job of explaining Provenge's big picture than the DNDN personnel did, probably because the discussion got bogged down with the immunologists worried about irrelevant MOA data.
(4) The guy from UCLA Dr. Dubinett emphasized to the rest of the
panel that it was OK to vote thumbs up to let Provenge on the market AND stipulate that DNDN continue with the ongoing trial 9902B. It seemed to me that many members of the panel WEREN'T EVEN AWARE that DNDN was ALREADY going to follow up and finish 9902B. I wanted to scream at the DNDN personnel to get up and emphasize that DNDN was already going to fully enroll and track 9902B, and the company would be receptive to the option of approval with stipulation on 9902B.
AI
