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Re: elMoose post# 97485

Wednesday, 10/02/2019 12:51:00 PM

Wednesday, October 02, 2019 12:51:00 PM

Post# of 140502
I pointed this out about a week ago that in their official legal filing they stated application submittal in Oct 2019 and approval in Dec 2019 - which based off FDA guidance, it is a max 30 days from application submittal to FDA approval. Their official legal filing should either have submission in Oct 2019 with Approval in Nov 2019 or Submission in Nov 2019 and approval in Dec 2019. Now with that said, even with giving them a couple of days to put a PR together (which is mind blowing it would take that long) then the latest we should expect to hear about FDA approval would be 2 or 3 days into December 2019 if they submit IDE Application on the last day of October.