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dmb2

04/21/23 7:34 AM

#587672 RE: hyperopia #587612

hyperopia, thx for your opinion, I will be disappointed if they file their MAA without Flaskworks but you are being pragmatic. Now that I see the extent of their info and control systems work it may have been too much. Although the Flaskworks system integration will serve very well, they will have an unprecedented level of connective automation when all is done, an impressive accomplishment for anyone. The capacity increase with Flaskworks is immediately necessary, so if not in the MAA they will hopefully file it quickly because the approval will probably take close to 6 mos, assuming comparable timing of MHRA to FDA.

GLTA