I’ll post this here as the other board couldn’
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Posted On: 06/08/2023 10:42:44 AM
I’ll post this here as the other board couldn’t handle it:
What was the update?
We already had proof that UHP could manufacture satisfactory product in Dec 2022:
“ 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. ”
The asap submission never happened, as a new batch with packaging was ordered. Again product was satisfactory BUT.,,:March 2023:
“ the laboratory leadership, believes (quality issues) resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier.”
These new batches were ordered to prove that Cutting packaging in the separate facility meets all Specs.
Just enough info to start waiting for THE NEXT PR. When they will announce (hopefully) the results of packaging the “satisfactory” product.
Sorry I just don’t get excited about things that are expected.
What was the update?
We already had proof that UHP could manufacture satisfactory product in Dec 2022:
“ 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. ”
The asap submission never happened, as a new batch with packaging was ordered. Again product was satisfactory BUT.,,:March 2023:
“ the laboratory leadership, believes (quality issues) resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier.”
These new batches were ordered to prove that Cutting packaging in the separate facility meets all Specs.
Just enough info to start waiting for THE NEXT PR. When they will announce (hopefully) the results of packaging the “satisfactory” product.
Sorry I just don’t get excited about things that are expected.
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