Replies to post #8991 on United Health Products Inc (UEEC)

[rodman]

Somewhat positive of a reply. ..."and some other important matters"
$5-$10+

[Waverunners]

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.