Replies to post #819496 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

I believe they applied to the UK first because they would have to be able to handle possibly 12,000+ cases of GBM a year, and they would not be able to do that without a fully functional Flaskworks Eden System.

And that’s fine, you’re welcome to believe that, and it may be true.

Doesn’t change the fact that investors thought they would be applying to the FDA

[Freddydunningkrueger]

I think they applied to the UK first because they believed that would give the greatest probability of approval as the MHRA would be more flexible regarding the data required. Our P3 trial results are unfortunately far from the gold standard RCT. I think FDA still requires patient level data if a external control is used (or did that just change recently?)

We couldn't get patient level data from the companies that ran the trials used to make the external concurrent control arm. LL states it clearly herself here at 6:05

https://www.vumedi.com/video/neurosurgeon-centric-clinical-trials-immunotherapy/