If they had chosen the FDA first, I don't believe that even now they could have submitted as they don't yet have an acceptable commercial production capability. Gary
I was tempted to give you a thumbs up for your post but then thought that maybe we aren’t seeing how supportive Linda has said MHRA has been. I believe MHRA has very high standards for cell based therapies and I know for a fact that their product release standards are higher which is designed purposely due to safety concerns with the handling of blood and cell based therapies. Clearing these hurdles paves the way for other less stringent jurisdictions but closed system manufacturing is the ultimate desire for highest safety standards at commercial scale. Best wishes.
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