Biotech Values

[croumagnon]

"Accelerated approval is not available on a survival endpoint."

I keep hearing that argument with respect to DNDN and I am not convinced it applies to the 9902b situation because of the following reasons:

1) Officially, the FDA can still approve based on the p=0.052 for TTP by stating that the survival data gives us the confidence that the 0.002 miss should not stop us from approving. Hence, we are back to an accelerated approval situation with 9902b being confirmatory.
2) I see the middle of the road situation as a very feasible one whereby the FDA says we approve Provenge but require you to complete 9902b enrollment prior to marketing Provenge. This seems to be the most likely scenario in my mind and will basically delay the marketing of Provenge by a coupel of months or so.

Thge FDA seems very amenable to approving Provenge, and you David have very eloquently made this point abundantly clear to the investment community. Therefore, I am sure the 9902b issue will not stop them from finding a way to approve while completing enrollment of the 9902b trial. Perhaps they will agree to do it a la Walldiver suggestion, whereby the trial will finish enrollement in Europe and thus allow DNDN to hit two birds with one stone: get the approval here immediately and use 9902b in the future for approval in the EU.