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Re: HoneyBager post# 161429

Tuesday, 05/09/2023 4:02:21 PM

Tuesday, May 09, 2023 4:02:21 PM

Post# of 175110
The consideration period on an IDE application for human trials is 30 days. In other words, no comment from FDA within 30 days after IDE submission means approval.

RDGL has been in pre-submission discussions with FDA regarding a possible Radiogel IDE application for 20 months now. Most of that is down time between RDGL submissions to FDA. It is absurd to consider all that dead time as "Our (PRnT) device is currently undergoing review with the @US_FDA.".

It's just a fact the FDA won't consider the device for human trials until RDGL submits the IDE application.
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