Replies to post #63731 on NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

What Pyrr fails to consider is that the trial can not be:

"deficient in trial design in its stated objective"

if the vaccine was simply a placebo, and if the immunotherapy was not activated properly and migrating to lymph nodes. If his position is correct, in that the vaccine is nothing more than a placebo, then the trial would simple show similar event rates between the placebo and vaccine arms as they randomize patients according to MGMT status. Neither the DMC or the regulators would recommend to stop screening if that were the case. The first interim would be too early to tell what the overall results would be.

The trial can only be stopped over:

"deficient in trial design in its stated objective"

If there are many instance of false PFS events due to immunotherapy in the main arm. But, that would also mean the vaccine is working, and those patients and that the imaging perimeters used in the study to not match the immunotherapy times.

Therefore, he can't have it both ways. The vaccine is either a placebo or it isn't. And if it isn't, he needs to rethink all his theories over the screening hold as he can't argue for "deficient in trial design" for an inactive non migrating vaccine.

On that end we know it is true that image stands need to change to account for immunotherapy mechanism of action, as iRANO recommendations are being made in neuro-oncology to address the "false progression" issue. But again I don't think regulators stopped the study, I think the company did to use those false progression to further de-risk the study. Obviously they need regulators okay to screen more patients, to new manufacturing hub, while they are at it. Anyway, time will tell how it all turns out.


http://investorshub.advfn.com/boards/replies.aspx?msg=122240532

[Pyrrhonian]

"Great post RK must read for anyone long!!! --md1225

Hey Chris, just want to make sure her saying the DCVax-L trial was going to add many patients and change primary endpoint to OS is what you thought was "great," because if so, I have to ask why you think it's a good idea to be holding 200k shares here. If that's true, the pps is going to bomb (even further).

I think at minimum they would need another 200 patients. Consider this example AVII first brought up on the EMILIA trial:

"In the original statistical analysis plan (SAP), PFS was the primary endpoint with OS as a key secondary endpoint. During the end-of-phase 2 (EOP2) meeting on August 8, 2008, FDA emphasized that “We encourage the use of Overall Survival as the primary efficacy endpoint, instead of PFS. You should be aware that PFS is subject to ascertainment bias, especially in an open label trial.” In response to the FDA’s advice, the SAP Amendment 1 (May 11, 2011) incorporated overall survival (OS) as a co-primary endpoint with PFS and increased sample size from 580 to 980 to ensure an adequate study power for OS."

Almost 3 years later and well into their ongoing P3 they made that drastic change. But of course in order to power the study for OS co-primary they had to increase n substantially.

So if you really think her post was great I'd sell.

That's just me though :)