Good points about the general lack of preparation regarding plausible MOA of Provenge on the part of DNDN's team. Probably wouldn't have made a difference, though, considering the internal politics between the OOD and CBER.
However, I would have to disagree regarding CEGE's chances of GVAX hitting stat sig in VITAL-1. I think the odds are well under 10%. The trial is only 80% powered to hit stat sig if the median survival of GVAX beats Tax's MS by 33%. There is no way that GVAX will come even close to besting Tax's MS by that much, for reasons outlined below. CEGE designed and powered the study at a time when they thought that Tax's MS was only 18.9 months. We now know that Tax's MS for asymptomatic patients was 23.0 months. I highly doubt that GVAX will even beat 23.0 months, let alone beat it in a stat sig manner. There is no crossover component in VITAL-1, there is going to be a large number of Central and Eastern European patients in the trial, and I think there will be a fairly large number of dropouts in the trial, who will still have to be counted as being in the intent to treat group. Administration of GVAX (the benign treatment of the two in the trial) means 16 injections per weekly visit for seven months. Ouch.
Edit: As for VITAL-2, rumor has it that enrollment has been all but halted at the expense of VITAL-1, due to CEGE's limited resources. Once VITAL-1 fails (and for CEGE's sake, they should hope it gets stopped for futility at the interim look), it will be years before VITAL-2 can get restarted, get completely enrolled, and then take time for the survival data to mature. Unfortunately for CEGE, they chose the longshot trial as the one to concentrate their resources on. The combo trial would have had a better shot at success.
AI
