NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

are there significant differences between the submission to the FDA vs MHRA? I mean, the trial data doesn’t change. Make two copies and send to both? Or else count on Orbis participation?

I am no expert, but I imagine there is much duplication in the submissions to the regulators that involves a large part of the submissions such as the complete file for each participant in the file and other such documentation that will be identical for the regulators. there will of course be some significant differences that will have to be unique to a particular regulator. But these will most likely not be too voluminous.
Bit IMO, once you have completed a BLA for one regulator, it should not take that much time and effort to modify it for submission to another. But I have never submitted a BLA, so take my opinion with a grain of salt.
Edit: I have now seen the post by Ex in which he points out some CMC issues and dealing with Advent v CRL