NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

While I hear what you with the rules were Gary, the regulators are very careful with trial for cell therapies, and this trial was started quite some time ago.

There were concerns, no doubt, with regard to pseudo progression, but if that had been the reason for the partial halt, there are very clear issues that would have been involved, and the reason for the "partial halt" would have been disclosed as a matter of safety involving the administration of DCVax, disclosures would have had to have been updated, it would have been a public event because you can't keep safety issues with your drug under the rug when you are administering it, not to mention it was a "partial halt". Partial. That does not make sense for a safety issue. You don't keep administering a drug that is unsafe, and only stop admitting new patients.

Then we see that at the end, there is a reduction of patients, but it appears that the reduction is in the number of placebo patients.

We can't know for sure. But it seems apparent that this treatment was halted because there was an ethical or safety issue involving placebo patients. Moreover, I do not believe that they could have halted it for efficacy for the very reason you suggest, there was some other complication, and that complication could very well have been pseudo progression, OR it simply could have been that the regulators haver very different rules in each country as to efficacy, it became a matter of a conflict of laws in that the FDA was perfectly willing to continue having placebo patients and felt it was critical to proving efficacy, but the Germans were OK NOT having the internal placebo or a placebo arm at all, given the evidence.

Hard to know, but in a multi jurisdiction trial, the layers of interweaved international law become very complex.

That's my speculative view of what we may be looking at in terns of this trial. Each trial has its own issues. Comparing to Gleevec without taking into account all there relevant factors, and I did not invest or follow the Gleevec trial at that time, it becomes very difficult to compare the two modes of treatment and their particularities. One can do so superficially and make superficial conclusions, but that is likely not very helpful in this kind of endeavor.