Replies to post #776839 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Flaskworks may have been referenced in the original MAA, but prior to SI 2025 No. 87 the MHRA had no legal framework to approve it as a modular Control Site.

EDEN is a piece of manufacturing equipment and could be approved as any other cellular mfg equipment is.

A "modular Control Site" refers to having a main mfg facility that other sites are patterned off of. It has nothing to do with the exact equipment used.

NWBO's MAA is with a single mfg facility, Sawston, and the existing process.

And no, that they collect autologous material from the hospital does not change that. Has been done for at least a decade w/o the new regs.