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Re: nathanial post# 166461

Monday, 09/25/2023 11:15:40 PM

Monday, September 25, 2023 11:15:40 PM

Post# of 176733
I'd think the FDA would want them to wait to submit the IDE until the testing results are in or why bother asking for it.

The only thing I could guess in your thought is if the FDA was completely comfortable with previous data on this subject, but wanted them to submit testing for IDE submission technical reasons.

I do believe there is a lot of data on this already, but again I'm sure they have to do it for technical reasons. If anything this will help create a stronger IDE than without if the data comes back positive.
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