What is UEEC planning? Lets hope the PMA submissio
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Posted On: 06/12/2023 8:15:41 AM
What is UEEC planning? Lets hope the PMA submission will also meet the packaging and labeling QC that FDA also requires.
"Concurrently with this effort, packaged product testing in collaboration with the company’s U.S. based, FDA certified packaging partner is being conducted to confirm packaging integrity, effective sterilization and other criteria for Class III products. This testing process is advancing as expected and the company anticipates its completion during the month of June as previously stated. Upon completion, the results will also be incorporated into the PMA application and the full application will be submitted to the FDA."
For a buyout any pharm will pay $5-$10+ but lets be real without achieving some proven production capabilities milestones would need to be achieved or we should only expect a $2-3 buyout offer!
JMO
"Concurrently with this effort, packaged product testing in collaboration with the company’s U.S. based, FDA certified packaging partner is being conducted to confirm packaging integrity, effective sterilization and other criteria for Class III products. This testing process is advancing as expected and the company anticipates its completion during the month of June as previously stated. Upon completion, the results will also be incorporated into the PMA application and the full application will be submitted to the FDA."
For a buyout any pharm will pay $5-$10+ but lets be real without achieving some proven production capabilities milestones would need to be achieved or we should only expect a $2-3 buyout offer!
JMO
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