Replies to post #730726 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

with safety data going back 20 years, might be in line for more favorable review.

I think this is wishful thinking Flipper, but I really hope Im wrong and they will take a reasonable stand because the question I would like to get answered when it comes to individual patient data is what the heck does the FDA want then? Another medical trial where patients die needlessly for then to be compared with treatment data and an outcome they already could learn from a BLA today. Its not for nothing Liau has been on record complaining about the FDA.

Why do you think the the American Brain Tumor Association has been complaining about this

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.”

And about Trump and the FDA. He suggested putting RFK Jr in control of the FDA
https://www.agencyiq.com/blog/trump-may-hand-control-of-fda-over-to-rfk-jr-heres-what-that-could-mean-for-fda-and-industry/
who then in turn said he would want to see entire departments at the FDA disappear. So to me, that sounds like slashing the FDA into small pieces..

https://thehill.com/homenews/campaign/4976746-robert-kennedy-potential-role-trump-administration/