Biotech Values

[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.