NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Your ignorance is blissful for you I guess.

Let’s take away your happy place.

Instead:

1. The original primary endpoint was only a surrogate, and it was confounded by a positive immune response called pseudoprogression. By itself, this only meant the trial would take longer.

2. The secondary original endpoint was the main endpoint, survival, and it was confounded by crossover treatment with DCVax-l, although perhaps still may show the treatment arm was superior to control arm. Comments from Doctor Liau, the stagnant early five or six censors before median, possibly being the six dropouts (their censorings are likely easily spotted in the 2018 SNO presentation graphs) still discussed as not available to compare yet in 2022 all point toward DCVax-l doing better than control.

3. Your decade long certainty that there was a futility recommendation back in 2015 is likely wrong, because, as you know, DSMBs do not have to recommend futility in a trial if only the surrogate endpoint is failing but the main endpoint of survival is still promising.

4. Consequently, the critical main/survival endpoint was still likely in the hunt.

5. It very well could be that control patients that did not receive DCVax-l early in the second half of the trial, when sicker patients were allowed in, were losing their immune systems and dying early and/or leaving the trial early (some perhaps just before progression), (dropouts) because they were not having part of their immune system decline restored by DC initiated t-cells. (Interesting, those censors did stay long enough to receive the base dose of chemo)

6. Because of the censoring and high amount of crossovers to DCVax-l, it would be logical to select new endpoints without knowing the early results.

7. Concurrent externally controlled endpoints made a ton of sense because it is in an indication where standard of care survival statistics are dismal and very consistent, so that comparison to the treatment is very reasonable. It also allowed two more massive advantages. It can allow the recurrent GBM population to be analyzed for pivotal therapy decisions, and it allows the use of DCVax-l without concurrent chemotherapy.

8. Finally, all this is accompanied by expected and consistent immune responses to treatment in patients responding to DCVax-l.