The battle of AI is getting pretty old on this board. These are messages boards and not novels. Most, if like me will do a quick glance and that’s it.. If I didn’t block Gary I would be willing to read more lines from his year end tax loss selling editorials than these argumentative novels.
AI, while a tool lacks originality and the human spirit.
This is no different than expert testimony from 2 opposing sides. Kind of cancels things out.
Commercially producing with B lab artisan production can still be commercial production. Scaling up to large scale C lab commercial production will take EDEN. That’s been the plan all along. Start commercial with artisan and transition to (scale up with) EDEN.
It makes sense for all parties concerned, including UK taxpayers.
All BS! You have no idea what you are talking about. MHRA would have rejected their application a while back if Flaskworks/Eden was necessary.
Remember, Kite could only produce dosage for 100 patients during the first year post FDA clearance.
None of the regulatory agencies will place such stringent volume requirements for a personalized immunotherapy product. They understand how expensive it can be to scale and that would damage the company financially even before they start! Thats not how things work. You start small and gradually expand/scale.
So you are implying that let's say NW didn't know how to build closed fully automated system yet and no immediate plans for it and had no discussion with MHRA about any such system even being possible and got the MAA approval under original application with artisan method . Then NW can't ever invent EDEN/Flasworks and build C labs and install implement and get validation and use it ever after in the future without submitting new MAA to MHRA?