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Re: SPORT19 post# 92784

Thursday, 08/15/2019 5:34:28 PM

Thursday, August 15, 2019 5:34:28 PM

Post# of 140484
So by rushing submission u mean ignoring everything they have been discussing with the fda for the last 10 months. By rushing submission, do you mean going thru the IDE approval process and getting fda approval for clinical trials. Which if any dd is done would realize the if fda grants fda approval then they have reviewed the data to date that would normally be reserved for fda approval and signed off on it.

Regulatory approval oversees by Jan 2020.