Replies to post #293337 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Wow. If that is true, that is awesome who did it thru DD. Thanks.

[DocLee]

Dendream, I think that your explanation is correct.

It is my understanding the German regulators can only have enforced a halt in the trial and then allowed it to restart if they were satisfied that the DCVax produced by the original method was not shortening progression-free survival and that they were also satisfied that the modification made by the Germans to the production of activated dendrocytes would likely improve the treatment outcomes and not the opposite.

I find it difficult to explain their closure of the placebo arm of the trial in Germany other than that as far as they were concerned the evidence was already showing that the treatment under study (DCVax-L) was showing a significant improvement in survival over placebo and that it was therefore unethical for the placebo arm to be continued as it would be denying patients the most effective treatment.

[biosectinvestor]

I agree with your suggestion. Obviously people will try to pick all of this apart, but without a real counter suggestion that makes any sense. Obviously it is all supposition.

[antihama]

While we've heard this hypothesis of all the screened patients in the trial after the hold being placed in experimental arm from the get go before, I like how you make it dovetail w LG amd DI insisting they were all randomized

What makes the most sense to me is that only 31-32 entered the trial after the halt and all of these patients were ‘randomized’ to treatment without the company’s knowledge. Since this maneuver actually weakens the study’s power, rather substantially, I contend that a regulator would only do so with the knowledge that the primary endpoint was a slam dunk. The DSM and regulators can be unblinded to the data while the company, investigators, patients and CROs are not, thus maintainIng the blind

This is supported by PFS being SS in alphapuppy's video in post 289738 (assuming the p-value needs to be under .05 and not .02 or.03 in some early speculations about splitting the p value w OS). We'll see soon if this becomes a theory or not.