NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

I like to hear other people's opinion on all issues, including why NWBO fell a few patients short of completing enrollment. In fact, I would like to hear your opinion. it's easy to criticize; not so easy to run the show as Linda and company do.
My theory may very well be completely wrong, but at least I've put a theory out there.
I can come up with others....
Maybe the safety board did its effecacy evaluation and it was so good, they showed it to the FDA and they're busy examining the data, and asked them to halt screening until they finished.
Maybe they applied for Fast Track or maybe the Germans and European regulatory boards are looking at data.
Maybe the FDA is spending five months trying to decide whether to close them down. ... Beartrap

First off, I would tend to agree that it would be reckless this late in the trial for NWBO to gamble that by putting a temporary screening halt into effect voluntarily when it did .... in the hopes that those already passed screening would bring the total enrollment to 348.
I am still going off the idea that Current Enrollment might not be much more than the 300 that NWBO acknowledged in a PR. Just because they said at annual meeting that enrollment is close to full, does not mean it is just a few patients away from 348 ...... in the grand scheme of things 300 enrollment is getting close to full 348 enrollment.

What is your primary theory, Beartrap, as to the reason for the temporary screening halt? And do you have any prediction on how long the halt might continue before it is lifted?

Regarding your other guesses:
Maybe the safety board did its efficacy evaluation and it was so good, they showed it to the FDA and they're busy examining the data, and asked them to halt screening until they finished.
I do not see why the FDA would ask them to halt screening in this scenario ... I would think the FDA would be happy to see the trial continue ... even just for confirmatory reasons.
Maybe they applied for Fast Track or maybe the Germans and European regulatory boards are looking at data.
If NWBO applied for Fast Track (honestly, I do not understand why they do not just get this Fast Track application going? Seems like other companies receive Fast Track approval prior to completion of their trial?), then I believe that this would have no impact on the trial continuing.
I doubt that the European regulatory boards are looking at any data ... especially if FDA is not looking at any data yet. Even if they were, I do not think this would cause anyone to request temporary screening halt.
Maybe the FDA is spending five months trying to decide whether to close them down. ...
Yikes, scary thought .... but I do not think this is what is happening either. I do not get the impression the halt has anything to do with safety. Why else would FDA look to close them down. FDA typically would not even be looking at any data, unless NWBO is convinced by Data Monitoring Commission to unblind the trial, right?

Note: I appreciate the guesses .... I do not have any good guesses .... I am stunned at this temporary halt, and the length of time it is taking. What info could NWBO have had to present to regulators ... and which regulators ... and for what purpose? Why is this taking so long?