NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

Pasting the 8-K filing and Exhibit 99.1. Exhibit 99.1 rules out safety, IMHO.

I also believe that this 8-K filing makes it clear that the company is operating with a new protocol. The pseudo-progression arm, which is being run parallel with the trail, is stated to be officially outside the trial. When I read "outside the trial", I interpret it to mean it will not be used in the main trial statistical analysis at any point. I believe that represents a change from sections of protocols that I've seen pasted on IV. We did learn they changed the statistical analysis portion last year, so no big deal there. But their 8-K statement officially makes it clear that the psPD were removed from the main trial count. Whereas before, 312 patients included up to 72 psPD patients (240 main trial + 72 psPD = 312); the new statistical plan includes 348 patients, and no psPD. Therefore, the main trial did officially increase 108 patients, going from 240 to 348. Not quite 36 patients, more like 36 + 72. I like facts. NW Bio should stick to only reporting all of them in their PR going forward as I'm watching. :)

Item 8.01 Other Events.

On Friday, August 21, 2015, the Company issued a press release confirming that the Company’s Phase III clinical trial of DCVax®-L for newly diagnosed Glioblastoma multiforme is ongoing and all patients in the trial are continuing to be treated in accordance with the protocol. The Company reported that over 300 patients have been recruited for the trial. The Company reported that the only change in the status of the trial is that new screening of patient candidates has been suspended while the Company prepares and submits certain information from the trial for regulatory review. A copy of the press release is attached as Exhibit 99.1.

The Company received various shareholder inquiries, asking whether the 300 patients are actually enrolled and being treated in the trial, or were just screened for the trial. On Monday, August 24, the Company responded by confirming that the 300 patients are actually enrolled and being treated in the trial. The Company also noted that being in the trial means not being in the Information Arm, and not being in the pseudo-progression arm, each of which are parallel with the trial but outside the trial.

A shareholder inquiry also asked what information the Company is submitting to regulators. The Company’s response noted that such submissions would not normally be discussed in the middle of a regulatory process or dialog, and that the Company plans to report when the process has been completed.

A copy of the shareholder reply is attached as Exhibit 99.2.

Exhibit 99.2

Shareholder Question:

There is a lot of confusion about your trial on the message boards. Are the 300 patients actually in the trial and being treated or are they just being screened? Also, what information are you submitting for regulatory review?

Company Answer:
Yes, the 300 patients are actually enrolled and being treated in the trial.

Also, being in the trial means that the patients are not in the Information Arm, and not in the pseudo-progression arm, each of which are parallel with the trial but outside the trial.

The supposed “confusion” about our enrollment is, once again, certain bloggers and commentators trying to turn good news into bad news about NW Bio and its trial. People familiar with clinical trials are generally aware that screening of patient candidates for eligibility is different than recruitment or enrollment of patients for treatment.

Regarding the information we are submitting for regulatory review: companies do not normally discuss such information when they are in the middle of a regulatory process or dialog, and we do not plan to do so either. We will provide an update when the process is finished and there is something to report.