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Re: flipper44 post# 585255

Friday, 04/14/2023 8:19:12 AM

Friday, April 14, 2023 8:19:12 AM

Post# of 698845
Agree with your timeline and think that the delay in the awarding of the Sawston MIA to add int'l level approval may have delayed the completion of the submission a couple of months.

Also, I think they may use the acceptance of the submission by MHRA as the signal to PR the submission for a few reasons such as this is their first rodeo and they will not want any missteps at this time.

Lastly, I am still hopeful that Flaskworks is included in the submission and not a post approval PAS. I roughly figure if they achieve product approval and Flaskworks approval by 10/23 they are doing ok given a 5 yr OS wait period.

GLTA
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