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Re: wrinklesobw post# 155283

Wednesday, 01/04/2023 10:24:07 AM

Wednesday, January 04, 2023 10:24:07 AM

Post# of 176918
Nonsense. Per RDGL, FDA suggested specific testing at first meeting. It was later reveled by RDGL what FDA was suggesting. To date per RDGL, FDA has suggested no other additional testing, nor has RDGL done additional testing, than the animal testing we're all waiting on. All other tests mentioned by RDGL are routine IDE requirements they were already aware of before the first meeting with FDA. While it is shocking some of these routine requirements were only completed in Nov. and Dec. 2022, further confirming RDGL wasn't doing squat towards IDE submission in most of 2021, those items have nothing to do with the additional testing FDA suggested at first meeting.
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