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Post# of 175211
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Alias Born 09/05/2023

Re: None

Friday, 09/08/2023 6:16:38 AM

Friday, September 08, 2023 6:16:38 AM

Post# of 175211
September 29th will be a huge day. This is the next and hopefully last scheduled pre-sub meeting en route to a perfected IDE submission. At this meeting, the final requests from the FDA will be discussed and hopefully resolved. The company will also include all questions and answers from every previous meeting with the FDA. In my opinion, this is an undeniable approach. Showing FDA that you have completed everything on the checklist and provided the positive results of each inquiry.
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