The talk back at submission was about NWBO because this is on MHRA not NWBO. My assertion is that this has all been part of getting manufacturing ready and that regulators can delay all they want to by simply passing the ball around to one another especially if NWBO was part of a pilot program that helped regulators to form the guidance that they ended up with. There were posts about the need for such regulations being discussed in committees at least two years ago that was part of shared due diligence on this board as I clearly remember the various types of manufacturing that regulator guidance would need to be readied for. The recent guidance posted is a result of this. If I recall correctly Dr. Mark Lowdell of INmune Bio commented on this need. I believe Lykiri might remember. Best wishes.
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