Replies to post #292183 on NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Hi Longfellow,

Data collected includes vaccine administration information, and any vaccine related adverse event. Patient MRIs will be collected centrally for future review. Patients will be followed for disease progression and survival.

This quote from the EAP trial confirms they intend to use this information if it is helpful. Yes, I see it being used as supportive material for this trial (for pseudoprogressors) and for a future rGBM trial, with patients who were true progressors.
I’m pretty sure I asked Dr,. Bosch in 2015 when I talked with him if they used this trial to gauge the Phase III and he said they wouldn’t do that. He also told me later in the same conversation that he often didn’t know what management was doing. The purchase of the Sawston property was a complete surprise to him, he said. So I doubt if he knew whether management or Dr. Liau were monitoring the progress of that group. On the other hand, I don’t think anyone could have just checked the patient records, since the patients were scattered across many hospitals. But I could see Dr. Liau and other hospital investigators checking their own patients.
This information could have gotten back to management and contributed to the length of the trial as they saw rGBM patients benefiting.
Another point of note, the fact that early progressors were pushed into the EAP trial may have held down the mPFS and mOS of the main trial, though I do realize that most trials removed early progressors, so maybe not. However, nobody else has ever followed these early progressors like NWBO is doing.
It is very interesting that the company changed from collecting data casually on this group through 2012, to turning it into a clinical trial. I think it was a very smart move designed to make the data indisputable when they chose to use it.

[Hspooner]

Longfellow95, I look for simple answers(Occam's Razor), can it be that they thought it would be prudent to following a smaller group of patients that had a worse prognosis in real time and gather and analyze all the data they produced? If they are doing as well or better than expected than that might be why management seem to be so confident in the end results of this trial.

[sentiment_stocks]

I think we’ll find the number of patients in that EAP trial to be around 90. It was intended to be 99, as you noted. Perhaps the screening halt played a part in it not being fully enrolled?