NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

Yes. Not crossover, but false progression in the experimental arm that could be at issue. Moving to OS would solve the issue, but that has the weakness that if DCVax-L helps after progression in the control arm, then the bar gets raised.

I wonder if, for the reasons you state, NWBO could be asking for patients showing long OS but early progression in the experimental arm, to be re-evaluated regarding progression. Maybe some new metric developed after the fact that can be applied after the fact. Such would seem off limits, but if this is what is going on, then I don't think NWBO bears the full responsibility for the problem. I think that the regulators and the broader pharma world should have been better prepared for these issues long ago. The groundwork should have been better laid for measuring PFS, etc., for immunotherapies. I know there is a new criterion, but maybe that has also proven inappropriate. To the extent that the regulators failed to properly anticipate such needed developments in such a promising space, I think they should be flexible on allowing the use of hind-sight and retro-active analysis.