FDA meeting..... "The focus of the meeting was to
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Posted On: 07/20/2022 6:11:53 AM
FDA meeting.....
"The focus of the meeting was to discuss the procedural approach taken by UHP to address certain observations made by the FDA in its initial review of its PMA application." "We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
Brian Thom, UHP’s Chief Executive Officer reported, “while the FDA does not respond in a piecemeal fashion in these discussions, their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application.
So lets see how Brian Thom and Mr Denser can ramp up the manufacturing process. There should be no learning curve but what about equipment. Recall the company did ask the auditors to write off old inventory and apparently fully depreciated (Let us hope not obsolete or non-functional equipment) equipment.
We are closer then ever to obtaining FDA PMA approval!
Guarantee you some pharm(s) are watching UEEC!
$5-$10+
"The focus of the meeting was to discuss the procedural approach taken by UHP to address certain observations made by the FDA in its initial review of its PMA application." "We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
Brian Thom, UHP’s Chief Executive Officer reported, “while the FDA does not respond in a piecemeal fashion in these discussions, their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application.
So lets see how Brian Thom and Mr Denser can ramp up the manufacturing process. There should be no learning curve but what about equipment. Recall the company did ask the auditors to write off old inventory and apparently fully depreciated (Let us hope not obsolete or non-functional equipment) equipment.
We are closer then ever to obtaining FDA PMA approval!
Guarantee you some pharm(s) are watching UEEC!
$5-$10+
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