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Alias Born 08/28/2019

Re: None

Wednesday, 09/23/2020 3:41:25 PM

Wednesday, September 23, 2020 3:41:25 PM

Post# of 13615
I'm optimistic about Hemostyp and potential in the market, but do agree with Waverunner that recent PR only indicates they are waiting final approval of their PMA application prior to the in depth FDA and/or outside panel review for FDA approval. With Covid applications, holidays around the corner, I suspect the majority of the 180 days period would be required if all goes smoothly with their initial filing. I feel like a reality check is due from someone else who has some FDA experience as it seems like people are still running with the idea that product approval is weeks away.

Additionally, I am interested to see the data posted on CT.gov; but remember, this is not a peer review process, and rather UEEC's responsibility to report scientifically accurate data. I'll be more excited when we eventually learn that the study was accepted into a legitimate peer reviewed journal-though, I assume everyone knows this has limited to no bearing on FDA approval. All that said, I'm happy with the rise in SP during these uncertain times and continue to be hopeful for a positive FDA outcome around 6 months from now.
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