NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

So why would the FDA be so inflexible in asking for the comparison of patient
level matched controls when that RA should have known that in the case that
their post progression DCVax-L treatment mandate could nix the placebo
group, the trial results, no matter how positive, could not be used for an approvable
BLA because there were no available ECAs that could provide such adequate patient
level matched controls? This would only show the FDA's idiotic inflexibility but I expect
that other RAs (e.g. EU) would be more flexible and should be considered by NWBO.

That's a very good question, but how do we know the FDA asked the control group of patients to cross to the treatment arm for reasons of compassion?
In any case, the FDA is being cold-hearted unreasonable inflexible and irrational. The FDA is asking for patients to die so they can be compared to treatment.