Replies to post #774060 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Reading problems ex ?. I distinctly said ambiguity on RWD/ECA WITHOUT IPD . Funny how you have always advocated that the FDA would dismiss a DCVAXL BLA because of the absence of IPD (you should make up your mind), which I largely agree with, and now you say they could have submitted a BLA without hindrance. Why do you think the American Brain Tumor Association is trying the FDA to change its mind on that


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

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