Replies to post #140451 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

canis star, in the upcoming publication the comparisons will only be between patients in the same trial not between controls in this P3 trial and trial patients in another trial or vice versa. Please read my earlier post today (140360); it postulates that the publication will show that most all of the PFS and most of the OS patients can be identified as control or trial patients without unblinding. The status of all the patients in the small arm of 33 patients (10%) who never received DCVax-L are all control patients who will be broken down to PFS patients, control patients who progressed but survived and dead control patients. The large arm (298 patients) contains the majority of the 98 patients who were supposed to be alive on 7/17 and all can be identified and all are trial patients who have not progressed (PFS). Remember there were about 83 PFS before 2/6/17 and by 7/17 this number may have been reduced to let's say 70. If we even have as many as 10 PFS in the small arm of untreated controls we would still have 60 PFS in the larger L treated trial group. The only thing the publication will not be able to reveal is the numbers of control and trial patients who were treated with L who have progressed but are still alive. We may have a total of less than 30 in this group but the publication cannot tell us how many control or trial patients are in this group.
In summary the publication can present the majority of the unblinded results and we will then be waiting for a more sophisticated and complete report hopefully by early next year.

[sentiment_stocks]

You can not compare this trail OS data with other trial SOC bcz no two patients are same and can have completely different prognosis. - canis_star

Well the lead principal investigator, head of NeuroSurgery at UCLA, and proud inventor of the DCVax-L Linda Liau would disagree with that statement. She seems to think there should be a way.

Yes, the patients do seem to be living longer with DCVax; and no, I did not mean to say that DCVax would not get FDA approval. I was making the point that, whether or not the study fits a particular category endpoint, there should be a way to get approval if the data shows that the entire group of DCVax patients (in both arms) does better than concurrent/historical controls who have not gotten DCVax.

Hope this clarifies the issue.

Thanks,
LL

Linda M. Liau, M.D., Ph.D., M.B.A.
Professor & Vice Chair of Neurosurgery

Director, UCLA Brain Tumor Program

UCLA Department of Neurosurgery
Sent from my iPhone

I guess we'll have to wait and see who is right - you or Linda Liau.