Replies to post #588706 on NorthWest Biotherapeutics Inc (NWBO)

[vator]

Are you still going on about PFS? Who do you think you are convincing? OS is the gold standard. PFS is just a marker to shorten a trial that may or may not determine efficacy.

[hoffmann6383]

I stopped reading after the optune comment. figured the rest was also bullshit

[The Danish Dude]

....that didn't change after bad data came out from the gold standard RCT trial, unlike DCVax

There's no "bad data".

45 approvals id'ed where FDA accepted ext. control data in benefit/risk assessment; doing so for many reasons incl. rare nature of the disease, ethical concerns wrt use ofplacebo or no-treatment arm, seriousness of condition, and unmet medical need

FROM

The Use of External Controls in FDA Regulatory Decision Making

13 authors from FDA, including Pazdur, published the article "External control arms in oncology: current use and future directions" in Annals of Oncology

External control arms in oncology: current use and future directions

Endorsed by Larry Smith as a huge positive

https://smithonstocks.com/northwest-biotherapeutics-fda-statement-regarding-use-of-external-controls-in-clinical-trials-is-a-huge-positive/

Then came FDA's own guidance on ECA's here in 2023

Considerations for the Design
and Conduct of Externally
Controlled Trials for Drug and
Biological Products
Guidance for Industry

https://www.fda.gov/media/164960/download



And waddayaknow!

Then MHRA in the UK endorsed historical controls, in the Pathway to a Cure report announced a month ago, in which british politicians from the All-Party Parliamentary Group on Brain Tumours, SPECIFICALLY pointed to DCVax-L



And last but not least we have Linda Liau being interviewed by JAMA saying at 7:59:

"There was a crossover arm designed into the trial and that was actually mandated by the FDA".

https://edhub.ama-assn.org/jn-learning/audio-player/18738384

There are no bad data. There are just ethical concerns and all signs saying

YES .... MHRA and FDA will approve.

Which is why MHRA in every way have been preparing for exactly that!

Info which can be read about here:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171701145

[Reefrad]

Optune had no placebo. Don’t bs us about optimal trial methodology.

[flipper44]

Optune never ever ever ever blinded.

Optune hid their long term follow up data once the last patient enrolled got to 24 months from randomization

Optune burns the scalp.

Optune causes headaches.

Survival at five years was decaying so they pulled the plug on follow up. Real survival at five years probably would have been under 4%.