NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

I appreciate the response but not fully getting it. NWBO applied using old manufacturing system dec 2023. If that manufacturing system was not good enough, application should have been rejected. Are you saying that now they are applying for major variation using flaskworks, since it is now in the new guidelines?
This is different than what people are posting that MHRA changed guidelines to accommodate NWBO and the flaskworks system because they needed improved manufacturing.

"My contention is that in fy2024, NWBO held off on the Flaskworks implementation until MHRA was ready. "
That still doesn't explain why the delay. It would explain a new delay, one from major variation submission, but not the delay until now. They submitted under old manufacturing system, which should have been accepted or rejected on its own merit. I don't believe they would have said lets hold off on decision until we can put in new guidelines.

according to slave1
"If Flaskworks was part of a variation then that variation was submitted during an active MAA review because that is the only time you can file one. Variations are not substitutes for full applications. They are adjustments or additions to a submission that is already on file and being reviewed"





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