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Sunday, July 17, 2022 8:25:46 AM
“The FDA has asked for no further information at this time”
Leading readers to believe that everything is complete and next step is the final decision.
However, just because they have submitted information doesn’t mean that information is to FDA standards, or in agreement with FDAs expectations.
UHP has a proven product but this is not going to push them to the start of the line after setbacks.
Time for UHP regulatory consultant to do his job:
“On July 13 the company and its regulatory consultant met with the full FDA team”
“…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. “
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