Replies to post #582661 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Multiple doctors on multiple occasions have confirmed the crossover was FDA mandated. I agree with your characterization of this other individual as "foolish".

[dennisdave]

Now that was interesting as the author does not seem to buy the idea that the FDA etc. demanded NWBO have a crossover because otherwise he would be pretty foolish to criticize the trial for including a crossover when there was no choice.

It may very well be that such is the author's assumption. Even so, by the author's logic there then also can never be a medical trial for lethal cancer ever again. Nowadays patients are not prepared to take one for the team and just die so the randomized arm can be old-fashioned compared to the treatment arm. Patients will not stand for it and walk out of the trial if they can not crossover to a working drug. Logic dictates the FDA directed NWBO to have patients cross as soon as they noticed the treatment was working. You just can not let patients die especially when you see the treatment is working.

So what after the patients crossed early in the trial is left to compare to? Only RWE right? Assuming the FDA did direct NWBO to not let just patients die then the FDA must have approved RWE data to compare the trial result with, which Im convinced has been discussed with the FDA as well.