Replies to post #79789 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

I think when the topic of the initial 33, of course we all thought they were enrolled in the actual trial. It then became apparent that we were errant in that assumption. Pyrr had also originally listed those 33 as enrolled in the main arm in his modeling. I believe this discussion started in early 2015 on i-village between Pyrr as JML and Avii.

http://www.investorvillage.com/mbthread.asp?mb=6543&tid=14639026&showall=1

As mentioned, the 22 number also matches up with the shelf filed in December 2011 in which they publicly stated it where Avii found it.

Shelf:

The Company has already enrolled and treated 34 patients in this Phase II trial, including 22 patients in the trial arms and 12 patients in an information arm, and the Company has similar numbers of additional patients in various stages of the screening and enrollment process. The Company plans to add a substantial number of additional clinical trial sites over the coming months. - page 27
https://www.sec.gov/Archives/edgar/data/1072379/000114420411071421/v242197_s1.htm

To me that means the Open & Double Blinded Information Compassionate Use Arm: Note, 11 of those 12-patients were enrolled prior to 2009 and 1 would make it into the 2011 -2012 Double-Blinded Compassionate Use Info Arm - RK

First, the first press release on the Information Arm stated that the patients in it all came from 2011 and 2012 so I don't think that patient came from an earlier time, although I suppose they could have snuck one in... but why?

During 2011 and 2012, in addition to conducting the trial, the Company also treated 55 GBM patients with DCVax-L on a compassionate basis in an “Information Arm” outside of the Phase III trial. These 55 patients received the same DCVax-L treatment regimen used in the trial, at medical centers participating in the trial. The 55 patients were not eligible for the Phase III trial because they were either definitely or potentially “rapid progressors”: patients with such an aggressive form of GBM that their tumor was already re-growing during the 6 weeks of daily radiation to the brain and daily chemotherapy which followed the surgical removal of their original tumor as part of the current standard of care.
http://www.nwbio.com/nw-bio-provides-update-about-phase-iii-dcvax-l-trial-for-gbm-and-information-arm-compassionate-use-case-patients/

Second: I don't believe the Info Arm is double-blinded because there really isn't any placebo for it, nor is the company blinded to the data.

"Including 22 patients in the trial arms"
When I see arms I see: Open arm. And Double Blinded. - RK

On the clinical trials history - on May 6, 2008, it shows the trial moving from an Open Label, Active Control, Single Group Assignment to a Double Blind, Placebo controlled, Parallel Assignment... and it now notes 2 arms, whereas it had previously listed nothing there.

So it would seem this trial now had two arms and I believe they meant treatment and control arms. - both part of the main arm.

Anyway, I had also confirmed these numbers with the company sometime earlier, and based on that shelf filing as well that from those 33 patients, 22 patients were enrolled into the main arm of the trial and 11 into the info arm.

[XenaLives]

Thanks for compiling that history - it does help put things into perspective.