Replies to post #802931 on NorthWest Biotherapeutics Inc (NWBO)

[theorysuit]

Sounds like they should have just redesigned a new trial instead they tried this gymnastics routine.....no wonder mhra doesn't want any part of it either. Not a surprise....

[Roman516]

NoGrow, a new day and your same old story, IMO

Per your opinion, "FDA & NWBO agreed that PFS was the primary endpoint - and DCVax-L didn't meet the primary endpoint. And right before the datalock, NWBO changed the protocol, the endpoints, the comparator - violating FDA guidance. Introduce significant bias into the trial that makes FDA very unhappy. And voila, FDA won't accept the data from the trial. That simple. NWBO has had almost three years to file with the FDA and has not."

So, that the "FDA & NWBO agreed that PFS was the primary endpoint"
No violation when the real "OS data results" where proof over the statistical guess PFS primary endpoints, the OS data trumps the PFS statistical guess.

The FDA knows the capability factors for NWBO and that is all that matters for now, IMPO. BTW, another day goes by, and you still fail to prove your claim that you have direct evidence that the FDA failed NWBO, so your bogus comments are just that, bogus per normal, IMPO.