NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Wow, you put a lot of work into that!

Look, you just don't change process after 300/348 are randomized. Or any significant number actually.

Manufacturing issue was a viable guess as to the cause of the hold at one point. Though I never really bought it as they had gotten so far for so long without any issues, and even had the very thorough PEI vetting for hospital exemption. That's extensive, and Frau passed the test, with tech transfer and process exactly as done by Cognate. Suddenly Frau fails out of nowhere? Or Cognate suddenly fails after making that many vaccines for years? It just never sounded right to me.

"The Company (NOT regulators) stopped screening patients IMHO. That went unnoticed for a short time, and then the Company was forced to address why patient screening stopped." --RK

You just don't know that. The 10-K sure sounds like regulators placed the hold:

In addition, our Phase III trial of DCVax-L is on a partial clinical hold for new screening for enrollment. We do not know what will happen with this partial hold. We may not be released from the screening hold and may not be able to complete the planned enrollment in this trial.

The wording there is very interesting. There is only one kind of "partial clinical hold" in the world, and it's the one regulators impose on an IND. And "be released" is a passive stance. It implies a third party that has power over the situation other than the one speaking and would do the "releasing."

If the sponsor was halting screening of their own accord, the trials registry need not have changed at all. They've slowed to a crawl or stopped enrolling completely despite having dozens of sites open in the past. Remember in that 10-k where they had 20 sites or something and just "6 patients enrolled?" The sponsor controls that flow. They can tell the sites to hold off for a time and they will. And they have to do this if they run out of cash (like they did when they were stuck at 22 patients in 2008). I think they were all told to stop screening and that the trial was put on partial clinical hold, as is their responsibility to disclose to all of the IRBs. The German trials entry apparently is the most thoroughly updated out of them all and this reflected that. Partial holds are material and are supposed to be PRed when they occur from a publicly traded company.

Manufacturing issue was never all that likely, imo. And now it's been 10 months and is almost impossible to be the cause. But definitely not because of some patent and change to TFF (not for DCVax-L yet!) or whatever else they plan to do AFTER approval. IMHO ;)

On another point, I always found this mention interesting in the 10-k, which I think first appeared in 2012:

There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval.

I've always been stumped by that, and they've never clarified. I know there is a mention that says EMA "informally" told NWBO they would not approve DCVax-L even if data were positive from this study unless they also performed additional early phase studies and a study in juveniles. Makes sense because really, this is the first study under IND 10206. The FIRST. Crazy...

Listen, when you WANT a certain outcome or want something to be true, there's a tendency to seek out and find "evidence" that suits only the outcome or "truth" you want. It's easy enough to do. But you have to shield your eyes and mind from anything that may dispel that "truth." Your post that I'm replying to is utter nonsense.

TGIF!