NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I'll try.



No, I don't believe the DMC believes a well designed trial in phase 3 is problematical under these circumstances.

The FDA worked with NWBO to move this to a phase 3 trial, keep it on track, cooperate as it should with an orphan treatment designation -- which included oversight when the interim analysis dimension was added in. (One reason for interim analysis, especially in very fast fatal diseases with no significant treatment options, and where safety is basically a foregone conclusion, is to make it possible to terminate the trial early and save more patients from death as long as statistical significance is present.) Consequently, the DMC should be satisfied that this trial is well designed, even if such design may possibly demonstrate better results than the phase 1 trial.

Note: In many ways, the exclusion of the early-subacute-true-progression patients (with the possibility of compassionate treatment) is also a blessing to those patients, because they can then step back and evaluate their options.

In my opinion, this is the most humane way a trial could be designed and still achieve profound data to reach an accurate conclusion.