NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

Okay, so I saw your next post, he's correct, it's the overall trial. Not that that point matters, as events are taking longer. It doesn't change that point, PFS events may be late, but vaccine events are not coming in too soon. Her comments wouldn't make sense if they were.

Actually, Management has explained the screening vs enrollment difference. They could have halted the expanded access as the enrollment period of psPD is done, and they don't need to spend on treatment of any more patients. Or, the screening pipeline is done.

http://nwbio.com/wp-content/uploads/2013/06/press2013.03.07.pdf

The Phase III study is still adding clinical sites even with the halt in place. They anticipate enrolling more patients, that is clear. The fact that their SEC statement referred to enrollment as good news, to me that means it was complete (per the 348 count). We are just going to have to disagree on that. But with the data submission the enrollment count may need to go up considerable if AVII's theory over the halt is correct, I'll agree with you there. My view is that the Company raised financing now, to get money in place to gear up for full steam ahead on enrolling once it resumes. The thing about this last capital raise is were not told what the money would be used for. That is unlike NW Bio, they always tell us. Yet at the same time we also know that they have no intention of discussing the Phase III data submission while it is in the midst of a regulatory process. And so I see this raise being related, and earmarked for DCVax-L, if the regulators agree to an endpoint change. It is the only thing that makes sense of why they would accept toxic terms, that aligns with my perception of the company executives not being corrupt. I do see the manufacturing pricing deal with Cognate was done in Cognate's best interest, but that doesn't mean that I think their behavior is criminal. At the end of the day, they are trying to get a GBM treatment through. If submitting for an endpoint change leads to better chance of trial success, then they will seek to do it. It would be a smart move. Again, assuming this is their pursuit, once they get the regulators go-ahead to proceed they could be done enrolling in a few months, they have the funds now.

If their screening halt is lifted soon and we learn that they do need to recruit more patients, within their PR they should provide details exactly where enrollment is at. (Hopefully we will learn 348 or more patients at that time! I would like to see they really weren't misleading on "good news" comments for once.) They also should specifically express when they anticipate completing enrollment and give clear timeline on when shareholders should expect to hear an update. Those kind of moves may minimize any perceived backlash over a trial enlargement. Changing the trial to an OS endpoint isn't a bad thing, if it leads to a better chance for success. Even if it does mean adding as many patients as you suggest to the trial, the study will not need a confirmation trial later on. I'm reviewing this as good news for GBM patients, as if the vaccine works, it's because it helps overall survival. Okay that we disagree there too.