It appears FDA is still reviewing the company resp
Post# of 591
(Total Views: 61)
Posted On: 06/06/2025 8:48:04 AM
It appears FDA is still reviewing the company response to the 2019 audit findings! "Bioresearch Monitoring (BIMO) audit of its initial 2019 clinical study. The assessment was issued by the Division of Clinical Policy and Quality on March 24, 2025, and the company submitted its detailed response addressing all findings on April 14. As of the current date, the FDA states that its review of the company's response is ongoing." What a bunch of bull but I understand a new case review team was assigned as the original reviewer took her DOGE retirement package and has exited the FDA! Stay the course! IMO we are very hopeful!
$5-$10+
https://www.otcmarkets.com/stock/UEEC/news/Un...?id=482135
"Pending the resolution of the BIMO Audit assessment, the company has completed all study tasks that can be accomplished prior to the IDE approval so that patient enrollment can begin as soon as possible thereafter."
rod
$5-$10+
https://www.otcmarkets.com/stock/UEEC/news/Un...?id=482135
"Pending the resolution of the BIMO Audit assessment, the company has completed all study tasks that can be accomplished prior to the IDE approval so that patient enrollment can begin as soon as possible thereafter."
rod
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