Replies to post #719469 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Hi Senti,

I’ve been wondering for a week now if Les is OK? He’s probably fine, but just wondering.

[antihama]

Wow Senti, a masterpiece of a post. Kudos!

[dennisdave]

Sentiment Thank you for your elaborate view of the FDA's guidance on the use of external controls for clinical trials with individual patient-level data/ ECA's. Can you then please comment on why the American Brain Tumor Association seems to be more concerned about the FDA's proposal to require the inclusion of patient-level data in marketing applications than you are?

Thank you for replying

03 May 2023

An FDA proposal to require the inclusion of patient-level data in marketing applications may prevent the use of external controls for some rare diseases, the American Brain Tumor Association said in their comment. “[I]ndividual patient-level data (IPD) is not always available for many cancers and other rare diseases,” they wrote. “This is due to many barriers that interfere with data sharing in healthcare.”

https://www.raps.org/News-and-Articles/News-Articles/2023/5/Stakeholders-want-more-clarity-from-FDA-on-using-d

[iclight]

Or you could simply look at a company who worked with the FDA on their external trial design for their GBM P3 in 2020.

After consultation with the FDA, the company can conduct a hybrid registration trial that allows for the use of matched external controls for two-thirds of control arm

And from your own references (did you read them?):

9 that include (among other factors) a valid comparison to a control.

Numerous doctors have already come out showing why this is not the case with the P3 and the ECA. A non-starter unless the FDA is stacked with NWBO shills.