NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

This was an adaptive trial and they, Pazdur and the FDA, also talk explicitly about trials like this and the impracticalities of traditional placebo arms. Additionally, the FDA is not in the business of wasting science or research to fit a rigid formula that has no purpose if the same concerns and issues can be addressed practically. And that is in fact the reason why they have adaptive trials for new technologies such as this one and why they allow for things like external placebos for trials like this one.

This was not an adaptive trial. An adaptive trial defines that in advance, and that was not the case here, The only feature that could be called adaptive was an modest increase in trial enrollment based on blended event rate, but that did not happen.

And again, you note how Pazdur talks about impracticality of traditional control arms. That is fine for future trials, but this trial was run with a traditional control arm and NWBO does not want to disclose what happened with it.