NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Doc, and thank you for your additional info and insight. I do appreciate it, as always.

I do not believe that the halt could be self-imposed 1) because then they know the reason and are effectively unblinded; and 2) the FDA would not impose a halt on a trial that has a voluntary halt already. The rules just do not work that way. In fact the FDA can’t impose a halt based in the trial unless they explain why and the reg predisposes them against imposing a halt if they can discuss first and resolve whatever issue is causing the issue, which would typically be something very serious. Then the FDA has an obligation to let the firm know in writing in 30 days if they impose a halt, but more frequently there is first an immediate communication as to why the halt is being imposed.

There are some other hairier issues I would rather not discuss, but long-short, the reason that makes the most sense for a regulator to keep it vague would be, “the Germans imposed a halt, so we must, resolve it there and we will lift it”, and then the Germans saying it is “temporary”, never lifting it, but the trial apparently is continuing. Then the DMSB notifies you that enrollment is completed, by you’re short quite a substantial number of patients, who just happen to be placebo.

I am not sure how no one tells them, but I do know that that leaves the original means of showing efficacy a problem because so many crossed over, they are short many placebo patients and the measure was to show benefit against the placebo arm. Then the regulator lets them know they are expanding the external controls rule and they can comment… and also maybe use that to address the issue.

As I said, it’s all deduction from here and of course the regulator also must by necessity be obtuse while helpful.

But I have a hard time seeing the other possible causes without a necessarily transparent set of issues that arise that them communicate the reason behind the partial halt. Absent the entices issue arising later, once the Germans do the Hospital Exemption review, and grant it, I can see no other reason for such a halt and for it not being necessarily a publicly communicated issue. Could be wrong though, because as you know, we are deducing from breadcrumbs and the necessary logic of various requirements and rules, ultimate facts and other things. What feels like a big hose could in fact be an elephant’s trunk.