Replies to post #13701 on Biotech Values

[walldiver]

DNDN: That is an interesting point that I hadn't considered until your post. I believe it would be a little premature. If 9902B completes the initial enrollment target of 275 patients in late Q3 or early Q4 2005, the TTP datapoint would probably mature for all 275 by the time DNDN finishes the BLA on 9901/9902A in 1H 2006.

When the company meets with the FDA in Q4 to discuss the merits of filing the BLA and opening up 9902B to all Gleason scores, they will have some options available. If DNDN is less confident about the possible 9901/9902A BLA after the meeting, then they can withhold the filing until the 9902B TTP triggerpoint. Unblind the 9902B data, and if it's stat sig, file for approval across all Gleason scores by using 9901 and 9902A survival data for market expansion beyond the Gleason 7 or less restriction in the 9902B SPA.

I think the company will also want some assurances in the FDA meeting that the Provenge BLA would continue to be CBER's purview, as CBER has been involved with Provenge's develpment since 1999. If the CBER personnel aren't that confident that they can prevent Pazdur/CDER/ODAC from taking control of any Provenge BLA, DNDN might just decide to wait for 9902B TTP data before filing, no matter how favorably CBER personnel receive the 9901/9902a data.

[DewDiligence]

>>Regarding 9902b. What about the DSMB. Would not DNDN give them all data from 9901 and 9902a so they could see what pts in 9902b are doing in comparison? If the comparison was positive would they recommend halting 9902b and approving the drug?<<

The 9902b DSMB might have access to the final 9902a data, but that doesn’t mean those data will have a direct effect on the DSMB’s decision making.

A trial that has an SPA—as 9902b does—can be halted by the DSMB for efficacy reasons based on criteria and timetables for interim data looks set forth in the SPA. The DSMB will not halt the trial for efficacy reasons except as explicitly allowed by the SPA.

(The DSMB can halt a trial for safety reasons at any time, whether or not the trial has an SPA.)

Because the 9902b SPA was established a long time ago, the criteria for interim looks in 9902b presumably do not depend in any way on the data from 9902a. Hence the short answer to your question is No.