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.