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Re: manibiotech post# 690431

Saturday, 05/11/2024 7:30:50 AM

Saturday, May 11, 2024 7:30:50 AM

Post# of 700810
Manibiotech, they gave us two dates, one on Jan. 24 where they said the MAA was validated, then on March 7th when validation was "confirmed".
Many on the board are assuming the second date means our application passed the through the first of the two phases of approval that comes 80 days into the process after which you may get a letter asking for more info. It appears we either did not get that letter or at least it did not delay the process or cause us to change anything. We think that because the quarterly goes on to state that they have not changed anything in their MAA. If the second "confirmed" validation is about completing the first phase toward approval, we may actually be moving faster than expected since it's only 70 days or so after we submitted the application.
This is all in : Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations on page 23
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