United Health Products Inc (UEEC)

[Waverunners]

Anyone still think we’re within a couple weeks of approval?
Looks like Hemostyp was finally accepted for further PMA review early Dec 2020.
The “within 180 days” to Approval clock I’ve been referencing since January has now begun.
Again, I didn’t want to be right on this fact, but it is what it is:

“We recently re-engaged with the FDA regarding the original PMA submission. During a meeting which took place earlier this month, we were able to confirm that our clinical and non-clinical data and analysis were deemed satisfactory. This position was amplified recently by the acceptance for publication in the Journal of Wound Care of a peer-reviewed white paper authored by Dr. Jerry Abate and members of our human trial team that describes the impressive results of this study. At the FDA’s request we are now pursuing certain manufacturing related testing and documentation, laboratory validations which are essential to establish our Quality Controls & Standards.“