Replies to post #38890 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Initially, I read the two PRs and thought there was a some issue with the screening process. At the same time, I took the regulatory review to mean they were indeed submitting something entirely positive, like a request for AA. I saw the two as separate.

A more careful reading of the PR showed that the screening issue now seems to be entirely related to the fact that 300 are enrolled. And as I've suggested in my hypothesis, if more than 48 are in the pipeline, and the trial will end up being fully enrolled as a result within three months, that would be an awfully good reason to halt the screening.

When the request was made to list "screening halted", it was found ***after the fact*** that no such listing exists. So the EU defaulted to "trial halted", and my guess is that the fact there was no category for this was not known by the company at the time.

From the PR...

The Company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing.

Now, if 48 or more patients are in the pipeline, the trial isn't officially fully enrolled. Hence, they can't say the trial is fully enrolled in the PR. Yes, they could have told us it should be in 3 months, but chose, for whatever reason, not to. Personally, I think it gets into the weeds too much because they've got to explain the whole rapid progressor elimination process in the PR.

So it would might have made the PR or the enrollment issue more ambiguous. They had most likely hoped that the "screening halted" designation would have gone quietly onto the EU site; and perhaps thought they had a couple more weeks before it was discovered. And it's surely obvious they have been trying to keep something big completely under wraps. That's why there's been no PRs for two and a half months. And this lack of the appropriate wording the EU pre-specified categories messed all that up.

Again, that's my take on the situation.