(Total Views: 109)
Posted On: 05/01/2025 9:15:09 AM
Post# of 594
Uplisting of UEEC to the OTCQB is great news but the FDA is disappointing that they do not site a deficiency that hasn't been addressed? Give me a break and lets keep reviewing the FDA study cited in previous meetings!!!
On April 25, the Food & Drug Administration (FDA) gave notice to the company that it declined to approve the company's Investigational Device Exemption (IDE) application to conduct the previously announced, follow on clinical study. The FDA did not cite any deficiencies from its review of the proposed clinical study design. Rather, it cited certain findings from one of the two Bioresearch Monitoring (BIMO) audits of UHP's initial 2019 clinical study that were conducted in 3Q/2024, and which the company had responded to on October 25, 2024 and again on April 14, 2025. UHP and the FDA are scheduling a teleconference in the next 10 days that the company hopes will resolve this issue and allow the clinical study to proceed. In the interim, the company continues to advance those clinical study tasks that can be accomplished prior to the IDE approval.
$5-$10+
On April 25, the Food & Drug Administration (FDA) gave notice to the company that it declined to approve the company's Investigational Device Exemption (IDE) application to conduct the previously announced, follow on clinical study. The FDA did not cite any deficiencies from its review of the proposed clinical study design. Rather, it cited certain findings from one of the two Bioresearch Monitoring (BIMO) audits of UHP's initial 2019 clinical study that were conducted in 3Q/2024, and which the company had responded to on October 25, 2024 and again on April 14, 2025. UHP and the FDA are scheduling a teleconference in the next 10 days that the company hopes will resolve this issue and allow the clinical study to proceed. In the interim, the company continues to advance those clinical study tasks that can be accomplished prior to the IDE approval.
$5-$10+
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