Wednesday, July 09, 2025 8:51:36 PM
NotSure2,
You are missing the reason the MAA would not be approved before the leukapheresis expansion and changed plans for Class B clean room space being set aside for Class C clean room space for use with Flaskworks. No way the MAA approval would have come before that change was made due to plans to expand IFRs to cancer from GBM. You just don’t understand the obvious give and take going on here before the MAA is finalized. For those thinking that a proper manufacturing preparedness plan for the big picture is not part of this, the guidance and role of MHRA to address all manufacturing concerns is either beyond your understanding or doesn’t square with your purpose for stating otherwise. Best wishes.
You are missing the reason the MAA would not be approved before the leukapheresis expansion and changed plans for Class B clean room space being set aside for Class C clean room space for use with Flaskworks. No way the MAA approval would have come before that change was made due to plans to expand IFRs to cancer from GBM. You just don’t understand the obvious give and take going on here before the MAA is finalized. For those thinking that a proper manufacturing preparedness plan for the big picture is not part of this, the guidance and role of MHRA to address all manufacturing concerns is either beyond your understanding or doesn’t square with your purpose for stating otherwise. Best wishes.
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