NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

I think we should take them at their word:
Quote:

However, at this point the Company believes that the potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment would take months, followed by further months for the recruitment itself.

I don't have time to respond to your full post but wanted to quickly share this. Does below sound familiar to the above quote?

In light of new information we have recently decided to withdraw the study protocol amendment for additional patients that we had submitted to the FDA last summer. It is now possible that we may not need to add more patients to the study or that only a smaller number of patients need to be added to the study to complete it in a reasonable period of time. Should additional patients be needed, we will submit a future study amendment to the FDA to seek their clearance to proceed.

Yes, Cel-Sci again.

They agreed to not enroll more patients and their hold was lifted (they had a few more "i's" to dot first though but this was part of it).

They had a bit of a stumbling block. After the above agreement to not enroll more patients the FDA switched from a partial hold to a full hold. The reasoning in that case was because all enrolled patients had completed treatment (since no patients were receiving treatment a partial hold is no longer relevant - it became a full hold). And they still had to change the investigator Brochure.

Then they amended the Investigator Brochure (as required by the FDA) and the Full hold was lifted (but they're not enrolling or treating patients, LOL).

So IMO, it simply doesn't make sense that the FDA would lift a hold if first the company agreed not to enroll any more patients.

That's how this works.

Just as there is no reason for a partial hold if no patients are receiving treatment but there are also other unresolved issues(it becomes a full hold), there is no reason for a partial hold if the company no longer seeks to enroll patients.

The patients were not "living longer" than theorized in the new protocol).

I'm not sure what you mean by this statement?

Have you seen the new protocol?

What is the expected blended mOS used for powering? (don't forget the 2:1 allocation.)

And, on a different topic, if you have seen it, look carefully at the primary and first tertiary endpoints (and the second and second tertiary endpoint). Something is wrong. You will be able to figure it out. I'm very serious about this: consider bringing it to somebody's attention. (Yes, I think the trial will fail but out of respect for the patients, I believe they deserve to have it analyzed correctly and I don't think either Linda would care to hear from me).