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Saturday, May 04, 2024 10:06:22 AM
If/when they announce if the FDA has agreed to File the application, Hemostyp will then (and only then) move on to the full review stage.
Typically UHP is quick with positive news, and vague with negative news. We’ll see what happens this time around.
Here’s a quote from the last time Hemostyp got to this stage successfully.
May 5,2021,— yes 3 years ago.
“following the resubmission of its application for Pre-market Approval for HemoStyp gauze on April 6th, the FDA has now accepted for review and commenced its Substantive Review of the application.”
Hopefully there are no resubmissions required this time around. As in that case, the original was submitted Oct 2020.
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