NorthWest Biotherapeutics Inc (NWBO)

[antihama]

You’re probably right that the Eden system will be submitted as a Supplement to the MAA but I’m still thinking due to the length of time it seems to be taking that they are looking at it as part of the MIA certification process and then it will be part of the initial MAA submission and not part of a supplemental MAA. I hear you that the commercial process is looked at more carefully but I believe/hope they started the Comparability Protocol process much earlier say 1st-2nd Q 2021 after getting the Fife loan in Nov 2020 where NWBO said it will be used “to help accelerate its activities related to its brain cancer program”.

Secondly, my thought is that Sawston has already shown they have GMP Quality Systems in place after the previous recent inspections and any additions such as Eden will be done via their Quality Systems. So, when they look at the Eden computer setup, Sawston will provide documentation that shows this. From my experience that’s what the Inspectors will be looking at. Caveat; my experience is from when Part 11 regs just came out and I know things have moved forward a lot. They have SOPs/Validation protocols in place indicating what is required and to be tested and they provide documentation to show that they did that. The only thing I’d be concerned w regards to its software/firmware code is to make sure that it cannot be manipulated and that they tested for that as part of their requirements. And Advent would have initially performed due diligence inspections looking at those bespoke vendors and have documentation to show they did that. I guess I’m looking at it that since Advent recently underwent inspections where the MHRA looked at their Quality Systems, I have faith that Advent will continue to pass the test rather w/o too much difficulty. Was hoping we’d get a PR today to make this discussion moot but its still fun to talk about this.