NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Critical review of the report on the DCvax-L trial: the trial did not meet its prospectively defined endpoint and post-hoc analyses with poorly selected external controls do not replace a proper prospective trial[emphasis added].

Hopefully regulators do not share this opinion because needless to say patients not NWBO cannot afford another Phase 3 trial.

If a new trial is imposed by the FDA but the UK approves without that then we might be able to survive long enough for real world proof of efficacy to prompt a revisit of that decision.

Under such a scenario it might be better to just go with using Direct in a Phase 3 for an indication where patients event rapidly and try to negotiate where if patients live past a certain time that we don’t have to wait until they event (in short we don’t punish patients for living longer).