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03/13/24 4:00 PM

#678368 RE: exwannabe #678365

exwannabe,

With L, MHRA can leverage their connection to the Specials program and MIA granted based on use of L. They also know that product release issues, based on standards more stringent than FDA requires, have been and will be adequately addressed by digitization and Flaskworks advances in preparation for ramp up. Bottom line, it’s a big submission but mostly well understood by the regulator who has been walking lockstep with Advent and NWBO for years. Best wishes.