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Friday, July 15, 2022 4:10:38 PM
As I’ve addressed previously, UHP moved manufacturing post human trials. Hence, they needed to prove they could make the identical product here, with equal raw materials in a factory meeting FDA standards.
UHP failed to disclose the move to FDA in a timely manner which meant the initial process for approval was on dated/inaccurate information.
Therefore, they we’re required to submit a major amendment ( as I’ve outlined and unfortunately been forced to debate here)
The amendment was filed poorly and incomplete by FDA standards which resulted in yet more wasted FDA time.
This PR proves my previous points, and clearly the FDA is saying “ get your manufacturing facts in order and we’ll get this thing APPROVED! But please stop screwing around. “
Recent UEEC News
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 07/30/2024 04:15:05 AM
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- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 07/15/2024 05:36:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:16:02 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/13/2023 10:05:42 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 09:10:10 PM
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