NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Longfellow95,

notes from Linda Liau 10/15/15 presentation:

The issue is because we have vaccine made for everybody and we are kinda doing a somewhat invasive procedure on these patients, the FDA actually required us to have a cross over arm when the patients progress.

So uh interestingly, the whole cohort actually, um, has not yet reached, uhh you know, its, I guess, um, its pre-determined event, um, how do I say this, pre-determined number of events. Um and it seems like everyone’s living longer than we would be expecting. So in reality, I think, you know, what we’re really comparing now is actually early DC Vaccination versus later DC Vaccination (big smile). And um, and I guess it’s a good thing that the patients are living longer (laughing), but it’s not really helping our study, because if the patients didn’t get anything, hopefully, the differences would be bigger. So that’s kind of another lesson learned about these trials. We have to consider all these different moving parts.

Um, it was difficult to, it’s certainly more difficult to enroll a patient without the cross over arm because they are going through this invasive procedure, and then tell them we’re making vaccine for you but then we’re just throwing it away. You know it would be difficult.

But so anyway, we’re still in the middle of this trial, it’s still blinded, and I actually don’t have any data for you right now.

The following are some notes taken on the rest of the presentation:

Began collaborating with NWBO and they helped initiate the multi-center P2 trial in 2007
(NON BLINDED but randomized)
Leukapheresis is quite expensive - so the placebo patients were NOT getting the leukapheresis and when they knew this, they were dropping out of the trial.