I purchased another block of 20000 shares and now own a total above 500K. Take a step back and ask yourself where are we now with the FDA PMA submission OR BETTER WHERE IS UEEC? Where we have come from can shed some light on where we are headed IMO!
United Health Products, Inc. (UEEC) has been diligently working on their FDA Premarket Approval (PMA) application process. Here are the key updates:
Initial Testing and Anomalies:
UEEC produced three batch lots of its HemoStyp gauze product to demonstrate consistent manufacturing results, a crucial criterion for PMA.
Laboratory testing revealed some anomalies in product pH level and moisture content, likely due to unintended partial oxidation during sample cutting and packaging by an external component supplier.
These anomalies were not part of the standard manufacturing process reviewed by the FDA.Testing results for other characteristics, such as chloride content, were well below tolerance thresholds in all samples.
Second Round of Testing:
UEEC is conducting a second round of testing for manufacturing consistency.
New batch lots have been delivered directly to the lab for controlled sampling.
These samples will confirm the uniformity and consistency of the company’s manufacturing process.
Packaging and Sterilization Testing:
Preparation for packaged product testing by the company’s packaging partner is ongoing. This testing ensures packaging integrity, effective sterilization, and adherence to Class III standards.
Timeline: Due to external service providers conducting the required tests, the exact completion time is uncertain. UEEC now anticipates that the entire process, including analysis and incorporation of results, may extend until the end of June 2023. The final consolidated PMA application will be submitted to the FDA once all necessary steps are completed.
Please note that while UEEC is diligently working on their application, there is no absolute assurance of approval by the FDA. JMO from reposted info available to all interested!
rod
United Health Products, Inc. (UEEC) has been diligently working on their FDA Premarket Approval (PMA) application process. Here are the key updates:
Initial Testing and Anomalies:
UEEC produced three batch lots of its HemoStyp gauze product to demonstrate consistent manufacturing results, a crucial criterion for PMA.
Laboratory testing revealed some anomalies in product pH level and moisture content, likely due to unintended partial oxidation during sample cutting and packaging by an external component supplier.
These anomalies were not part of the standard manufacturing process reviewed by the FDA.Testing results for other characteristics, such as chloride content, were well below tolerance thresholds in all samples.
Second Round of Testing:
UEEC is conducting a second round of testing for manufacturing consistency.
New batch lots have been delivered directly to the lab for controlled sampling.
These samples will confirm the uniformity and consistency of the company’s manufacturing process.
Packaging and Sterilization Testing:
Preparation for packaged product testing by the company’s packaging partner is ongoing. This testing ensures packaging integrity, effective sterilization, and adherence to Class III standards.
Timeline: Due to external service providers conducting the required tests, the exact completion time is uncertain. UEEC now anticipates that the entire process, including analysis and incorporation of results, may extend until the end of June 2023. The final consolidated PMA application will be submitted to the FDA once all necessary steps are completed.
Please note that while UEEC is diligently working on their application, there is no absolute assurance of approval by the FDA. JMO from reposted info available to all interested!
rod
