Dendreon Corp fka DNDNQ

[walldiver]

Back in town after three weeks overseas. There is an SPA in place for 9902B, so Provenge won't get approved unless 9902B survival data comes out stat sig...and even if it does, and DNDN/Provenge appear to have satisfied the terms of the SPA, the 9902B data still has to get past the FDA biostatistician slice and dice. After seeing how the FDA raised the bar on Thelin after the SPA was signed with ENCY, you just can't discount some bit of potential bad info that only the FDA can see.

On the other hand, there could be enough cumulative pressure on the agency by that time that they could be more lenient than expected at the first interim look. Perhaps DNDN/FDA/DSMB will have some kind of understanding in place that lets the company see all of the survival data if the interim look is not stat sig. This would be done in case the alpha allocated for the interim look is in the 0.01-0.015 range, but 9902B's interim p value comes back between 0.015 and 0.05. The FDA would have to bend its Pazdurian standards somewhat to grant approval in this example, but the debacle of the past couple months has shined something of a flashlight in the mainstream press on the agency's cancer drug approval process, and this could work in DNDN's favor.