Replies to post #384430 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

No outsider knows if the original PFS endpoint was/is significant. The trial ran on long enough for a survival endpoint to replace a surrogate (PFS) endpoint as primary. Survival is the gold standard. Survival expectation is what any patient primarily requires when choosing a therapeutic. Survival will be determined by comparing the treatment group against both an external control and an internal control group. This trial might also be able to provide sufficient efficacy data regarding recurrent glioblastoma. The company was blinded, according to their public statements and documents, until a long time after the SAP was amended. If the trial demonstrates significant survival efficacy, it will have done so without subjecting additional control only patients to a greater chance of dying.

[MI Dendream]

When they amended the protocol to increase the size a bit and change the PFS trigger to 248, the also split the alpha between the primary PFS endpoint and the secondary OS enpoint. The study was now powered to detect a difference at 98% certainty (p=0.02) rather than the original 95% certainty (p=0.05). By doing so, they elevated the OS endpoint. There is your reason. Need I post the PR?

None of this need be done with an interim efficacy analysis. Everyone who bother to do basic DD knows that no interim efficacy analysis was ever performed.

Not even a nice try LC.

Reading the old comments everyone who trashed AF ultimately got it all wrong with Germany and the rest.

Do we know exactly when the DMC dissolved?

>>adamfeuerstein Comment

You don't resize a study without a reason. And the DCVax study wasn't just resized, it was radically altered by increasing by 125% the number of PFS events required for the final analysis. If you believe these changes were made without an interim analysis, you know nothing about clinical trial design and conduct and should not be invested in biotech or drug stocks.

NWBO issued two press releases in which it stated clearly, definitively, that an interim efficacy analysis was underway. It's been almost a year, where are the data?