Replies to post #813640 on NorthWest Biotherapeutics Inc (NWBO)

[ROS-CH]

If you write :...'Regulatory approval late 2026', you
mean for Flaskwork and C-Unit, right ?
Because if I recall, approval for DCVax could come earlier
as the MAA is based on artisan-production.

[theorysuit]

SInce when is automation required for regulatory approval. You do know that this trial was performed under the manual process, right? And that NWBO hasn't even finalized this yet, but let's just keep saying MHRA is reviewing it...LMFAO

The stuff that you guys make up on this board is unreal. Automation wasn't performed in these trials. The only review this application will do is the manual process. But keep kicking the can down the road for this 27 month and counting process. It has already failed and nwbo is protesting it. It is that simple. Wow now we are can kicking to late 2026. That would be 3 plus years.....LMFAO at these justifications/excuses.

They need each other to reach GMP approval, machine can't get there unless it's in a GMP unit, the unit can't be approved without a GMP machine installed. Interesting catch-22, but solvable. Once installed, with testing and obtaining regulatory approval, figure another 4-6 months, or late 202

6.

[Doc logic]

barnstormer,

We are thinking along the same lines. I do believe that once the GMP version of Flaskworks is or was done everything else including approval for artisan is a go ahead because transition is doable and fully accounted for because of a Flaskworks GMP final version accepted for installation. The details will likely work out along the lines you suggest. Best wishes.