NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Thanks, FemIke. And I appreciate your posts as well. thanks

You are absolutely right that MHRA can approve regardless of NICE’s appraisal. MHRA doesn’t care about pricing. However, MHRA cannot approve a product based on a manufacturing process that the sponsor is already abandoning. Once a company shifts from manual => automated manufacturing during an ATMP review, the regulator must evaluate the final commercial CMC pathway, not the temporary bridge process.

And every ATMP company that made this shift saw extended review time for the same reason:
Novartis CAR-T: +7 months (CMC)
Kite: +9 months
BMS Breyanzi: +11 months
Orchard: +6–10 months
Bluebird Bio: multiple CMC-driven pauses

None of these delays had anything to do with cost, reimbursement, or NICE. They were pure MHRA/EMA/FDA CMC extensions caused by a change in the commercial manufacturing route. NWBO is following the exact same pattern.

Also, a key point that gets overlooked: If the sponsor is transitioning to automation, MHRA always waits for CMC completeness before approving. They need comparability, validation data, QA/QC integration, and stability of the final manufacturing process. So yes MHRA can approve without NICE, but the MHRA cannot approve a product on a process that won’t be used commercially. That’s why the timeline expands when Flaskworks/Eden is added during review.

And NWBO made it very clear today what the commercial production pathway is: it’s Flaskworks/Eden, not artisanal manufacturing.