NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

It’s becoming clearer that NWBO has not been idle since they submitted MAA. If you re-read the Feb 6, 2024 PR, it’s obvious they’ve been working through the regulatory pathway for Flaskworks approval behind the scenes.

“As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L.”
That line alone tells you that Advent (not Flaskworks directly) was the entity responsible for submitting Flaskworks validation data to the MHRA.
So, from Feb 2024 onward, NWBO’s key task was to get that closed automated system qualified under Advent’s GMP license. That’s a regulatory process, not an engineering one and it easily explains the extended timeline.

Yes. I early 2024 they announced these plans in a forard looking statement. Then they updated in the 2025 10K:

During 2024, the Company’s Flaskworks subsidiary and a specialized contractor developed a GMP-compatible prototype of the Flaskworks system for a “closed” manufacturing process for DCVax-L. Another prototype, with smaller dimensions, had been developed in 2023. The Company has determined that the smaller prototype will be preferable, to enable more units to fit in each manufacturing lab. Production of the GMP-grade units will be timed to coincide with the timing for buildout of Grade C labs in the Sawston facility. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients. As previously reported, the Company views the Flaskworks program and system as a centerpiece of efforts toward scale-up for potential commercial operations.

So, that program has been on wait while NWBO decided it was not yet ready to build the C rooms. That process may have started, but they have still not had the actual devices that need to be certified delivered.

So, no, they have not made progress on that as LP decided it was not time to spend money in 2024.