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Re: rtg123 post# 157068

Tuesday, 02/07/2023 1:09:21 PM

Tuesday, February 07, 2023 1:09:21 PM

Post# of 175560
So RDGL shows extreme caution for years now. Did two meetings (2nd and 3rd) with FDA just to set up test plan that hasn't even started yet. Has now requested a 4th meeting to go over test results addressing routine IDE requirements. But you're saying RDGL will then just throw caution to the wind and submit an IDE application without FDA feedback on the test results first? Maybe, but seems very unlikely given pattern to date.
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