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So just re-reading the announcement, it said that on the 24th...

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    So just re-reading the announcement, it said that on the 24th August, FDA has confirmed that it has moved to the 'Substantive Review' phase.

    https://hotcopper.com.au/data/attachments/2502/2502078-59051390d83b61ee2c59cda46fc62a55.jpg

    Today is the 24th of September, which is 31 calendar days after the 24th of August, bringing us into the realm of the MDUFA Decision!

    Sit tight folks!
 
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