Not a “moot point” at all. In fact it’s just the opposite.
UHPs recent actions under the guidance of PMA consultants prove that.
14 months ago I correctly stated:
“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.”
11 months ago UHP finally admitted (or finally just learned) this was in FACT the case.
6 months ago UHP enthusiastically stated:
“The measured physical and chemical characteristics of the new product were shown to be effectively identical to those of the HemoStyp gauze product utilized in the company’s human trial, a key step toward demonstrating a supply of equivalent product for planned commercial production. The company will now incorporate these laboratory results and other data into its PMA application for submission as soon as possible”
But 4 months ago under consultation realized to go forward with the PMA —multiple batches must be run and packaged to prove the whole process could result in Identical product to the Human Trials. And the process must be repeatable.
2Months ago the results were announced as unsatisfactory and new tests batches and packaging were ordered.
Good for UHP to NOT move forward with a PMA submission until all aspects of the product are IDENTICAL, As it would have been rejected.
The Consultant and UHP clearly agree with ME and are NOT willing to submit the results in a “give it a shot” manner going forward.
Hopefully, the current tests are a massive SUCCESS. If not, press pause and return to the drawing board until they get it right.
This is the process. FACT.
