NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

They did not go for accelerated approval, they went ahead and extended the trial to prove OS. Another trial would do not good because the regulator wanted the crossover and adding crossover again would create the same problem and not having it at this point would be deeply unethical.

So your point makes no regulatory sense.

They have extensive evidence from a variety of trials and real world evidence indicating there is a response, there are virtually no side effects and there is an extension of survival not explained by anything else. Requiring a control and another trial for a rare disease is unlikely given that they have approved other treatments that literally failed and had serious side-effects.

It may make sense to you, but not to a broader audience, not to doctors or patients. If it were an early end based on a surrogate, then they could ask them to prove survival. But they can’t in this context ask them to do a new trial, with an internal placebo, no crossover, given what everyone knows. No one would join such an unethical trial.

I think you have ignore that basic logic because you want so badly to prove you’ve always been right.