NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

I agree with Flipper that we could have around 40 or even more beating hearts at 5 years. The reasons are the following.

First of all, from the rGBM arm there could perfectly be more than the 2 patients shown at 5 years on slide 39 of the final presentation, because those 2 are counted from recurrence, not from randomization.

On the other hand I'm starting to think that part of the 35 people not included in the trial arms of the final presentation (nGBM arm and rGBM arm) were patients in the initial control arm of the trial (part of the 99) that at some point, after the study started, were thought to be progressors, but then it was realized they were pseudoprogressors.

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 could not be part of 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 could not be part of the nGBM arm.

That would explain why we had 13 left censored patients (lost to follow) in the JTM interim publication for the first 19 months from surgery and now we have zero in the treatment arm for nGBM from the final presentation.

I was wondering what happened with these pseudoprogressors from the control arm that recieved DCVax at pseudoporgression. This theory kind of solves that question for me as not being included in the rGBM arm, that I think is the correct thing to do. But I could be wrong.

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 my 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 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 progression.

Other thing that could be in agreement with my theory is that in slide 11 of the final presentation there are 81 PFS events coming from the 99 placebo arm patients. So there are 17 patients (81 - 64 ) that were clasiffied as PFS (not as cPFS (confirmed progression-free survival)) but not included in the 64 rGBM arm. So they could correspond to the pseudoprogressors initailly thought to be progressors.

In a previous post I mentioned that according to my numbers, part of the 35 patients could be living longer. In the Table below are these calculations. The rows in yellow correspond to the 2 trial arms from the final presentation, the dark gray corresponds to the interim JTM publication and the light gray is calculated from all the other infomation in order to obtain the same mOS of the interim publication



With all this in mind I expect even better results that what we have seen until now. I think this trial is a total success. We just need to be patient.