NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Has been quoted and cited many times. From FDA guidance on external control arms:

Nothing in there that underlines your claim that the FDA rejects ECA if there is no patient level data. As a matter of fact the guideline does say this

"This guidance does not address other types of external controls, such as using summary-level estimates instead of patient-level data.

You just referring to a guideline or the FDA, just as Doclogic does, makes you an idiot. Put your money where your mouth is and start QUATION the FDA. Pock pock Pock pockPock pockPock pockPock pock chicken. from bcplatforms.com

BC Platforms’ Global Data Partner Network provides patient level, longitudinal, and geographically diverse real world data (RWD) for use as external control arms (ECAs) in randomised human clinical trials. Through the use of RWD, fewer patients are required to be directly enrolled in randomised clinical trials, enabling broader patient inclusion and shaving significant time off the clinical development process — saving cost and resource — while facilitating improved access to new drugs, in new markets, for the global patient population.

. There is an industry around summary-level estimates that should not exist according to you

The sponsor can know results of efficacy IAs prior to datalock.

Not if the sponsor plays by FDA rules which what NWBO did, you liar. You have zero knowledge of FDA regulation and are as dumb as a monkey's ass. You keep lying about this and have no evidence what so ever

The designed in OS was between the 233 that were randomized to -L and 99 that were randomized to placebo. That failed badly.

No they didn't they improved mOS x3 vs SOC

You continue to argue it would make trials impossible to stick with this,

I didn't argue this you arrogant lying ass, I literally quoted The American Brain Tumor Association saying that, but you ignored that as you ignore all logi.

You twist lie cheat. It is not possible to have a normal conversation with you since you keep ignoring reliable resources and MDs, refuse to quote the FDA and twist everything that anyone says.