Replies to post #3314 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Nice,

Thanks Long!


Funny, I was also going to cite that May 2012 press release, but then I had to get a family member to a medical appointment.


The only thing I'd add is that in that press release, they state NWBO's work/changes with the FDA for that date was/were memorialized in writing the same day on Clinical Trials .Gov.


If you go to clinical trials .gov, then head to the historical changes for May 17, 2012, "side-by-side differences" you'll see under the section listed as "8," the relevant language. You'll see the before and after drafts. I'll let people go there and see for themselves.


New Language:

The primary study endpoint is PFS (progression free survival), and the first secondary endpoint is overall survival (OS). Other endpoints include performance status, immune response, and also safety. Interim analyses to assess efficacy are incorporated in the trial design.

[ou71764]

Flipper/Long

Thanks for the reference to the May 17, 2012 press release. I was searching under "SPA" and not getting a hit. The trial design was agreed to by the FDA, so that's all I need to know. I agree, IMUC's problems aren't our problems.