NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

gnawz: I have a very strong opinion on whether crossover should prevent early termination for efficacy. Unfortunately, so far, someone that I know has far more familiarity with the workings of the FDA disagrees with me on the point. Scarier, this guy doesn't just know more than me, he seems to know more than just anybody I have heard post. He is on another message board.

I think it is completely obvious that if the crossover group does not fair as well as the experimental group that there needs to be termination for efficacy if the numbers are statistically significant. But this other poster is totally familiar with how the FDA thinks. All I could conclude was that either the FDA doesn't think very well sometimes, or this other poster does not know as much as he pretends to know.

The crossover group might only get 6 months less DCVax-L treatment than the experimental group, but it is early on. And if that proves to be a significant problem for the crossover patients then of course that is a reason to stop the trial.