NorthWest Biotherapeutics Inc (NWBO)

[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