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BLKRP17

10/02/19 2:55 PM

#97508 RE: SPORT19 #97501

I'd like to say that the FDA shouldn't reject it due to the previous PR's that stated they were working very closely with the FDA to ensure a smooth process. Todays state of affairs makes that impossible to believe anymore. I'm still holding onto hope IDE gets submitted around the first week of November and gets approved the first time.