Replies to post #555458 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

One would wonder- maybe someone more familiar with the process could answer- 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?

Orbis still requires two submissions.

The huge difference would be CMC. For biologics, this is a very complicated section of the BLA.

For UK, NWBO would have Advent as the manufacturer.

For US?

Are they going with CRL in the submission. In that case they need a deal with CRL to get them to spend the cash to ready for a PAI (the inspection that says CRL can produce DCVax-L). And then CRL needs time. Some recommend a year to be ready., And the stability testing would be 6 months and would not start until after CRL has been paid to set up an implement the process.

Will they go with Advent for the FDA BLA? This has different issues. To start with, Advent would need an import approval in the MIA which they did not have for the MIA(IMP). Then we have the question about logistics for the PBMCs that could effect quality.

[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