Replies to post #798890 on 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.

[attilathehunt]

because they all know NICE wont approve artisan.

They don't have to...NICE can approve the C lab pricing even though it is not up and running yet...

Company pricing is reflective of C lab up and running...They don't make as much while the artisan method is used....HOWEVER...We get approval...share price increases....dilution, if needed, is at a lot higher price (due to approval)...Why wait 6 months for C lab approval? Doesn't make sense...MHRA approves with Artisan method....Reimbursement from NICE using C labs pricing...Less revenue now but we get the approval mojo!!!

[Doc logic]

FeMike,

I believe both you and dennisdave have perspectives with merit and that either one could be the case. The bottom line is that manufacturing is the centerpiece of each perspective and that is where partnerships and the future of the platform has rested since the science was initially looking promising back in 2012 and additional clean rooms were purchased in 2015 with the hope that a successful business model would be developed. U.K. represents price constraints and the US represents volume constraints with regard to artisan method. Flaskworks had to be the answer for the success of murcidencel with both price and volume and to provide the runway for Direct. Best wishes.