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Re: Lykiri post# 571726

Monday, 02/27/2023 8:59:59 PM

Monday, February 27, 2023 8:59:59 PM

Post# of 822591
His reply is a word salad mess. It makes absolutely no sense. His response to you is unintelligible to me. Can you make heads or tails of it?

I wonder why he just doesn't answer your question.

Dear XXXXX

The MIA process is separate to the MAA process so as long as the potential MIA applicant has a clear vision of the product they intend to manufacture then an application can be made prior to an MA application. They must be GMP inspection ready and be able to demonstrate the capability to manufacture the final product during the inspection.

Kind regards

Rick

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