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Re: georgebailey post# 544043

Monday, 12/05/2022 5:57:10 PM

Monday, December 05, 2022 5:57:10 PM

Post# of 694541
I agree that based on the June presentation, I would not completely eliminate the possibility that Flaskworks could be included. The time it has taken, also leads me to believe there's a chance. We are close to 4 weeks past the median time for MIA approval timeline. As we already had the GMP for the compassionate use manufacturing, I would have assume that the MIA would have been done on the shorter side of the 90 day average MIA cert. That being said, it is probably more likely it is not included.
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