NorthWest Biotherapeutics Inc (NWBO)

[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/