So what is the status of the FDA IDE submission re
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(Total Views: 85)
Posted On: 05/28/2025 9:46:53 AM
So what is the status of the FDA IDE submission review? I have sent a request to the company for a pr update to the IDE submission but no response has been received. This leads me to conclude that Brian Thom has had discussion with FDA who agreed to take under consideration the company's case for additional consideration. Willing to let this unfold considering no deficiency was sited in the IDE response and no adverse results were stated in the 2019-2020 J&J and UEEC clinical research study! Could be a gamble but this does to present a buying opportunity!! Fingers crossed!
$5-$10+
$5-$10+
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