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Re: Smitty5150 post# 673958

Thursday, 02/22/2024 1:03:36 PM

Thursday, February 22, 2024 1:03:36 PM

Post# of 702473
My feeling is they will submit right after MHRA approval so that FDA can’t refuse or delay.
Almost 4 years from data lock and 2 months after completing doubly reviewed 1.7M page application by two separate consultants ( second that bought or merged with the original one ) , it’s very hard to imagine that the application has not been ready . If not they should at least explain as this is not the normal timeline or industry standard by any stretch of imagination
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