Replies to post #512521 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

meirluc,

The vast majority of long lived patients came from the original treatment group. Early looks would have seen that strong KM trend by 2015 after having seen 2013 safety data compared to 2015 Spring Refresh blinded data. Remember, “enrolled to the point statistically necessary”. Best wishes.

[biosectinvestor]

I think we are saying the same thing. If you don't have an internal placebo group now, because of the crossover, then randomizing more patients to placebo and delaying their treatment is unethical. Because patients were living longer, it was not futile, clearly, so there was no reason not to put those patients directly into the treatment arm. There were also no safety issues for treated patients. But having patients enroll and doing experimentation on them for no purpose by continuing the crossover notion, when there already were not enough placebo patients, was likely viewed as unethical. So it effectively became a 2 arm trial with 1 arm of treated patients and another arm of recurrent/crossover patients. And then the obvious fix would be an external comparison and the FDA and other regulators were already in the process of liberalizing those rules, so it worked perfectly.