NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I agree with what you're saying about UCLA, but I just wonder if between them they couldn't have an agreement to let them try the NWBO owned technology. It just seems to me that they're really working closely together, Dr. Liau no doubt is the lead on any manuscript or presentation being developed for peer review of the trial, and I would suspect that she, and others on her staff, are assisting in the preparation of the BLA as well. In short, they have a very close relationship, why not also permit them to work with the FlaskWork device as long as such use would be permitted in the trials being run there.

My understanding is that production of material used in Phase 1 and 2 trials is not nearly as monitored by the regulators as material used in a Pivotal trial. If a Phase 2 is considered registrational, then Pivotal quality material must be utilized. I would think that if the FlaskWork device were used in Phase 1 or 2, it's acceptance as being Pivotal, and/or Commercial quality could be established. Of course the difference in our case is that no mass production facility is required, unlike all normal BP products. If the FlaskWork device works in Phase 1, it should qualify to provide commercial vaccine once we have an approval.

Of course I know nothing about what may, or may not be added to either the tumor lysate, or product of the leukapheresis before it's added to the FlaskWork device, or used in the cell line. I there is something added that requires production approval, it would need to be dealt with separately. On the other hand, if it's the addition of readily available pivotal quality materials, it should pose no problem.

I know that Dr. Liau is not employed by the company, yet I suspect that a fair amount of her time is spent on DCVax-L, and that UCLA is compensated. I just don't know if UCLA and the company are working together on other things, like the FlaskWork device.

Gary