I think the more likely it is that the CTGT Office in CBER remains quasi-independent from CDER/Pazdur/Office of Oncology, then the more likely Provenge gets approved, assuming a p value of 0.05 or better. Even if the p value is better than 0.01, which is the probable alpha allocated for the interim look, if the Office of Oncology somehow takes control of cancer vaccine purview, the SPA could just get thrown out, i.e. the "not invented/negotiated here" syndrome. Especially considering the person who will likely still be the head of the OOD, all bets are off.
Now, I don't believe that the cancer vaccines will be taken from CTGT's purview. I also believe that the more pressure can be applied to the OOD by the advocacy groups, the less likely CTGT will lose the purview. But I don't believe it's a total slam dunk, even if the results are stellar. If the Cox regression p value is a big improvement over the log rank, you can bet that the reviewing biostatisticians in either office will be all over it. I don't think we can call anything a slam dunk after what happened after the Provenge AC meeting.
