NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Let me state this more clearly, because I was thinking it through as I wrote it.

Not necessarily the statement is for purposes of the initial determination for the trial involving nGBM. There is no such limitation on the diagnosis for rGBM.

For the determination of recurrence the trial was required to be consistent, for statistical purposes, even though it was learned during the course of the trial that the standard method alone was flawed and not valid for pseudoprogression. This is an unfortunate part of the ridiculous formality of trials, that you’d have to continue to diagnose in this manner, in order to remain consistent, knowing, in fact, that you’re getting a false result. It is not the requirement for patient care and it would be medical incompetence to presume recurrence when you know it hasn't happened. Further, that is really only for patients in the nGBM context. Upon recurrence, doctors would certainly do their best to be sure that was the case. Further, such patients this applies to, this analysis, are ONLY the STANDARD OF CARE patients, NOT the treatment arm. Pseudoprogression was a problem primarily for immunotherapy patients. But again, there is no limitation on diagnosis and scanning for rGBM patients after they've recurred, that would be a bizarre situation and unlikely given the many care centers and doctors participating who generally have no interest one way or the other. You might presume the doctors are incompetent with the standard of care, placebo patients, but it's highly unlikely.

Once the patients were diagnosed as recurrent, it would be medical malpractice to diagnose such patients as “recurrent”, when they were not, in fact, recurrent, if you have the knowledge to diagnose that they are rGBM.

There was no original protocol for the rGBM patients, so they will discuss that I am sure with the regulators. However, there is also no reason to doubt the survival results compared to patients with the same or similar diagnosis in trials that happened concurrently. The reality is, they were compared to similar patients with similar diagnosis in concurrent trials. There is no difference in that circumstance. And again, these were the placebo arm, standard of care patients, where pseudoprogression was not typically seen previous to immunotherapies.

Remembering that pseudoprogression difficulty in diagnosis happened in the treated arm for immunotherapies but also that limitations as to diagnosis are only for statistical collection, not for care, helps to keep one honest. Once patients recurred, they could get all kinds of additional care, including Optune, and that is registered in the details presented in the JAMA paper. The rGBM patients were getting the standard of care only, so pseudoprogression likely was not the issue it was in the treatment arm and even if some of them are, again, you’re comparing to patients in a standard of care, getting the same exact care, in concurrent trials. No difference. So the survival results are comparable.

This only works to confuse people who cannot think this through.