you really are now becoming ignorant and incredibly bad at MHRA regulation. You refuse to read what Im saying and worse what NWBO is saying in their last PR
You keep ignoring the last PR where NWBO istelf stated they changed the way they commercially manufacture DCVAXL. Do you need reading classes?
And you’re arguing against a point I never made. I never disputed that Artisan/B-lab has demonstrated they can manufacture DCVax-L for clinical and Specials use. That’s exactly why they have an MIA and why Sawston exists in the first place. But hey if you have to resort in lying about what I said we are done.
The MHRA quote about “fully demonstrating your ability to consistently and correctly manufacture your ATMP in order to obtain an authorisation” is not about whether a lab has ever made compliant batches. It’s about whether the intended commercial manufacturing route, the one the company actually plans to use for market supply has been fully demonstrated and assessed as part of the MA. You are exactly like ex dodging reality.
NWBO’s own Nov 20 PR states that the Flaskworks closed system in Grade C is “central to large scale-up of production.” HELLO are you THERE THERE?
The question is not:
“Has Artisan ever made DCVax-L correctly?” I never claimed it didnt
The real question is: “Can MHRA legally grant a marketing authorisation based on a process that the sponsor itself no longer considers its commercial pathway, while a different, automated Grade C route is being built as the actual commercial platform?”
That’s where your logic falls apart. AGAIN
If Flaskworks/Grade C is the commercial route (NWBO explicitly stated it is “central to large scale-up”), then that is the process that must be validated, inspected and reviewed as part of the MAA
But hey whatever make syou sleep at night
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