NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Adam, you ask:

How do you explain the prior NWBO press releases and public statements made by Linda Power that the interim efficacy analysis was underway?

It’s one thing to say it’s “underway”, and another to say it’s been completed.

In their December 10, 2013 Press Release, they definitely state they reached the required number of events (at the time it was 66) to conduct the first IA. But remember, it’s the DMC conducting that review (not Linda or NWBO) as is stated by the company in the same PR.

As is normally the case, this interim analysis of the Company’s Phase III trial data is being conducted by an independent Data Monitoring Committee (DMC), with assistance from the independent CRO (contract research organization) managing the trial. The independent CRO audits and confirms the raw data, and delivers it to the DMC. The DMC then reviews and evaluates the data and reaches an assessment, which it delivers to the Company. The most common DMC recommendation is to continue the trial as originally planned, although it is possible in rare instances that the DMC may recommend that the trial be stopped, either because of safety or futility concerns or because of unexpectedly high levels of success. The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded.

http://www.nwbio.com/first-interim-analysis-of-nw-bios-phase-iii-gbm-trial-triggered-by-reaching-required-number-of-events/

What obviously happened was the safety interim analysis was done, and not the efficacy interim analysis. Remember, the DMC chairman for the trial, Dr. Curt Furberg, had to remind you of this…

“As the Company has stated clearly and specifically in its public announcements, the DMC has not conducted any efficacy analyses and the DMC has not provided any access for the Company to any clinical trial data,” commented Dr. Curt Furberg, Chairman of the DMC.  “The DMC adheres to established clinical trial monitoring procedures and does not release any data while the trial is ongoing.  This is an important issue, and it is surprising and troubling to see inaccurate claims being made by commentators who seem to lack a fundamental understanding of clinical trial monitoring.  I have been on the DMCs for more than 60 clinical trials, and I have never experienced this type of attack.”

http://www.nwbio.com/nw-bio-corrects-ongoing-false-claims-by-feuerstein-about-phase-iii-trail-of-dcvax-l-and-interim-analysis/

I’m sure Linda thought at the time (back in December 2013) that the efficacy analysis was to be done as they'd reached the required number of events. Obviously, the DMC chose not to do so at that time, and instead chose to “enhance” the trial by increasing both the number of enrolled patients, as well as the number of events required to trigger each interim analysis. Most likely, that decision took enough time that it wasn't passed on to Linda at the time they issued that PR. When was it finally shared with the company? Maybe sometime in March (?)... as I believe it was sometime then when she suggested trial enlargement was a possibility in a public presentation of hers.

As it stands now, the first IA for efficacy (yes, safety 1st IA was already done) will be/was conducted when they reach(ed) 149 events. Second IA is at 198 events. And of course, the final number of events will be when they reach 248 events.

Now you can poke and laugh at Linda all day long about her “error” in thinking that the efficacy analysis was underway, but it wasn’t, and I would strongly suggest she didn't know it on December 10. And no amount of jokes at her expense will change that.

You surely don’t actually think an interim analysis for efficacy was done, Linda was told, and she is hiding the results, do you?