NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

The company makes it very clear, in their very well chosen words, on December 8, 2017 that they were NOT going to enroll the remaining 17 patients - while in the same PR they state the hold has not been lifted.

As a result of the partial hold, the Trial has not enrolled the last 17 of the total 348 patients. To date, the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with the Protocol. The Company is pursuing ongoing dialog with regulators. 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.

Accordingly, the Company is no longer seeking to enroll the last 17 of the 348 patients.

These are the facts.

The company stated they would not enroll the 17 additional patients on 12/8/16 and that the hold is still in effect.

Two months later the company states that the hold has been lifted.

You are pinning an assumption onto the fact that the halt was lifted because the company agreed not to enroll the 17 additional patients.

And you are basin this on the fact that the sentence following the announcement of the partial hold lifting states that the company had also publicly announced this previously, and that they had also informed the FDA that they would not do so either.

That's a stretch to me.
I understand it merits considering, but it is not a fact. Based on the fact, we do not know whether that the halt was lifted because they didn't enroll the 17 patients. Period. And you and ex and others have presented it as a fact... and now Adam is presenting it as fact in his article when he writes,

The Food and Drug Administration lifted the hold in February 2017 — 18 months later — but in exchange, Northwest Bio agreed not to recruit any additional patients, meaning the study fell short of its enrollment goal.

I mean, he is flat out stating that the company make this an exchange - don't enroll, we'll lift the halt.

I mean, do you think that is a fair representation of the facts?

By the way, I looked at my post regarding Adam's article and I had quoted this portion (with your name) as if Adam had written it. I just want to be clear that was a mistake. This was meant to be my rebuttal to what Adam had written as cited above.

Wrong, wrong, wrong. Now please don’t tell me Adam used ex and Avii as his “outside cancer expert" sources? lol. Anyway, NWBO announced on December 8 that they believed 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.” Then on Feb 6, 2018, almost two months later, they announced the halt was lifted. My guess is that the FDA saw the light, and whatever might have been promulgated by people who might have been receiving honoraria who may have had a conflict of interest, or two, was finally chewed up and spat out. IMO

That is often difficult to do. For example, I just noticed that the BSSR was still "in play" after the "enhancements". That was to occur at 80% of planned enrollment. That would be 84% of actual enrollment on the enrollment chart. That coincides with the hold (as close as the planned IA in the summer of 2015 does). So that thickens the plot a bit.

I'm not sure what effect that would have as the protocol stated that if enrollment were less than 348, they would make no change. Are you thinking they decided instead to make a change? Feel free to spice that passage up a bit more so I can get the point you are making.