NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

What Pyrr fails to consider is that the trial can not be:

"deficient in trial design in its stated objective"

if the vaccine was simply a placebo, and if the immunotherapy was not activated properly and migrating to lymph nodes. If his position is correct, in that the vaccine is nothing more than a placebo, then the trial would simple show similar event rates between the placebo and vaccine arms as they randomize patients according to MGMT status. Neither the DMC or the regulators would recommend to stop screening if that were the case. The first interim would be too early to tell what the overall results would be.

The trial can only be stopped over:

"deficient in trial design in its stated objective"

If there are many instance of false PFS events due to immunotherapy in the main arm. But, that would also mean the vaccine is working, and those patients and that the imaging perimeters used in the study to not match the immunotherapy times.

Therefore, he can't have it both ways. The vaccine is either a placebo or it isn't. And if it isn't, he needs to rethink all his theories over the screening hold as he can't argue for "deficient in trial design" for an inactive non migrating vaccine.

On that end we know it is true that image stands need to change to account for immunotherapy mechanism of action, as iRANO recommendations are being made in neuro-oncology to address the "false progression" issue. But again I don't think regulators stopped the study, I think the company did to use those false progression to further de-risk the study. Obviously they need regulators okay to screen more patients, to new manufacturing hub, while they are at it. Anyway, time will tell how it all turns out.


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