NorthWest Biotherapeutics Inc (NWBO)

[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 :)