Replies to post #8996 on United Health Products Inc (UEEC)

[SPORTYNORTY]

UEEC--Excellent and ACCURATE posting.

Thank you.

[Scumbag Fraudsters]

Those are statements of opinion, not fact.

You didn't provide a shred of evidence to support your supposition.

You're just guessing at what's causing the delay - like those who guessed it was caused by COVID.

I could make all sorts of guesses, but without FACTS to back 'em up, it's pointless.

[Chrism0000]

So I would pray & guess this finally ends before summer?

[Combat_Medic_Hur6]

Well said. Agree. I worked for a medical device company and after going through multiple FDA “hoops,” it was cleared and has been doing great ever since.

[Waverunners]

Note to all:
Stop doubting me.
March 24 2022
As I mentioned before, all delays are manufacturing related.
There is nothing the FDA can do until UHP can prove capable of producing hemostyp gauze in the new facility exactly as they used in the human trials.
As a result, until they get a line running at Strouse (or wherever they intend to make it now) the FDA can not complete the approval.
The only question the next PR needs to answer is when/where will this happen. Even a small sample run will suffice.

https://www.strouse.com/
UHP is not currently listed as a partner.

In hindsight they now realize they should have left manufacturing in China active until the PMA was complete and then moved it to the US and simply applied for a PMA supplement to get clearance for the move.

These are statements of fact.