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shoondale

05/03/24 12:32 PM

#13611 RE: Pragmatic D #13610

"we doubt that shareholders will hear about it. We expect it will be just like when UEEC applied for PMA approval for Class III in late 2017, there will just not be any updates, like it never happened."
https://seekingalpha.com/article/4300303-united-health-products-press-releases-cannot-be-taken-face-value
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Waverunners

05/04/24 10:06 AM

#13615 RE: Pragmatic D #13610

Pragmatic, another accurate post re the current state of the PMA and where it stands with the FDA. Thank You, Hopefully UHP updates Shareholders in a timely manner.
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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band aid

05/04/24 12:55 PM

#13616 RE: Pragmatic D #13610

Pragmatic, I think we here the FDA has accepted the PMA and my feeling is that because of the 3rd party RCA the file is completed fully and we begin the who knows how long wait for approval. JMO