NorthWest Biotherapeutics Inc (NWBO)

[CogDiss 1188X]

My view of the Gottleib speech is very different to most commentators here.
To me, the takeaway message was aimed at BP, the message being; 'you keep running the single arm open-label trials, demonstrate a tumor response rate, and we'll keep approving', and 'We won't expect you to use OS, because it takes too long and denies patients the drug for too long, and you won't need a placebo arm because it's unethical..'

Tend to agree with you on this. His emphasis seems directed toward ICIs/TargetedTherapies with biomarkers. If you have that, the barn door is wide open (sorry, I have a predilection for horse metaphors).

Of course, the ASM seemed to suggest that this free wheeling FDA spirit might extend to DCVax-L. I have my doubts about that but maybe LP knows something I don’t. That’s probable. Maybe Cofer tapped Gottlieb’s phone. Or something. Or whatever he does but he can’t say cause otherwise he’d have to...Thanks for the NCCN link!!