Replies to post #588508 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Thanks for sharing hyperopia

[rkawong66]

Reading between the lines, it would seem from your post that MIA for Advent/Sawston may have been granted w/o the Flaskworks automated production equipment being fully ready for commercial production. Is that even possible? Would UK MHRA give commercial license for production on a system that has not yet proven itself? Or, could you give more clarity on the 'biosensor' and 'programming' issues (if known)? Were the issues resolved? Or, are they now the subject of a 'comparability study' to validate the FlaskWorks system by the end of this year (2023)?

[dmb2]

hyperopia, thx, all sounds rational and based on mgmt discussion is more probably accurate regarding Flaskworks status.
Since I believe the commercial license is a general GMP licensing I think the MAA could still incl Flaskworks, though it may then push review out a little and add an inspection. I have been hopeful that the bell lap here will have NWBO in a strong finish, which to me includes Flaskworks. But what concerns me is if they were not able to include FW in the commercial licensing was it due to in-progress validation or incompletion of the comparability studies? If the former that would mean the comparability studies followed post validation which was post July as it would not make sense to perform the comparability studies with an unvalidated system. This could stretch timing some to incl FW in the MAA, but not unrealistic.
Now just to make this a little more intriguing it is possible to perform the comparability studies with a validated FW system which is not integrated into the MES or EMS as it may be and this may help reduce timing. Then they could use compassionate care batches for integration of process validation into their MES/EMS.

I appreciate your perspectives on this and will remain optimistic for FW inclusion but will realize out of the block it may be sub-optimal aseptic processing with one or a couple of stages to follow on. It is a fascinating mfg case with significant cold chain logistics embedded. Even a BP would be challenged with this level of integration of soup to nuts.

GLTA