NorthWest Biotherapeutics Inc (NWBO)

[VuBru]

Meirluc - FWIW - I keep coming back to LP's statement (paraphrased) that what appeared to be a bad thing (FDA halt) would turn out to be a good thing. Given the comments in the recent pub and communications on finding optimal ways to adjudicate PFS, it seems to me the most obvious way of interpreting LP's statement is that the trial was halted because it appeared that the DCVAX group was actually progressing faster than controls (a bad thing), but that this was due to pseudoprogression related to the DCVAX-induced immune response (a good thing, necessary to attack the tumor). In context of Senti's nice summary, they may have delayed ending the trial because of the difficulties in interpreting PFS (they believe the p value may not be significant), they are buying time to improve adjudication using state of the art methods in hopes of improving the PFS p value, and as time goes on and the long tail continues, they are simultaneously bolstering the case for demonstrating efficacy using OS (the more clinically relevant measure, even though a secondary outcome). Much as I hate the wait, I think what they are doing is the best option for increasing the odds of eventual approval.