NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

What I think is that those 35 patients were in the initial control arm of the trial (part of the 99) and at some point, after randomization, they were thought to be progressors from SOC, but then it was realized they were late pseudoprogressors from SOC.

If this is the case, because of being initially thought to be progressors, they received DCVax after pseudoprogression. As a consequence of that, these patients were not classified in any of the two trial arms. They were not progressors when they received DCVax, so don't correspond to the rGBM arm and they didn't receive DCVax at the beginning of the trial, so they also were not included in the nGBM arm, but benefited from DCVax.

The main reason why I think that is the case is because in slide 11 of the final presentation there are 81 PFS events (this is PFS, not cPFS or confirmed progression-free survival events) coming from the 99 placebo arm patients, but in the rGBM trial there are only 64 patients. There is a difference of 17. How would you explain that difference if it is not the reason I mention? I'm open to read any possible reason for the difference, but I think that is. I would like to know what you and others think about this difference.



I also think those patients could be the reason for having 13 left censored patients (lost to follow) in the JTM interim publication for the first 19 months from surgery and then zero in the treatment arm for nGBM from the final presentation, as I explained in previous posts.

And finally, I find possible that some SOC pseudoprogressors where not excluded from the trial because they pseudoprogressed after randomization.

Sluicebox mentioned in his/her reply to you that Doctor Ashkan said that less than 10% of the patients didn't crossover. That would reinforce this theory, because we know that at least 89% received DCVax-L ( (232+64)/331 = 89%). So maximum 11% didn't receive it. If the number that didn't receive it is less than 10%, that would mean that part of the 35 patients received DCvax at some point and could correspond to the group of pseudopregressors that received DCVax at pseudoprogression.