![](https://investorshub.advfn.com/uicon/564105.png?cb=1547105359)
Thursday, July 16, 2020 3:24:24 PM
https://titanmedicalinc.com/letter-to-shareholders/
Highlights from a schedule perspective:
June 2019, they started GLP studies to support the IDE submission (animal and cadaver studies)
GLP studies completed July 2019 with IDE submission to occur shortly thereafter.
Human Trials were expected to be completed, with patient follow-ups and subsequent 510(k) submission as early as December 2019.
So on their first run through the scheduling process last year, they were looking at as little as 6 months from starting GLP procedures to filing the 510(k). Allow up to 6 months for FDA approval. 12 months from start of GLP to FDA approval.
They planned to set up the dry lab for surgeon training at Chapel Hill; that is now underway.
So if we finish software development by end of this year (should be fairly easy for a competent development team) we have a basis for a timeline.
Since it looks like one of the milestones was to be around late October, maybe THAT is the milestone - software done and GLP studies begin. That could conceivably put FDA approval in early Gregorian Q4 next year. Acquisition completed by Christmas 2021! Then REALLY HAPPY NEW YEAR!
Message in reply to:
I AM LOOKING FOR IDE...
TIMELY - STORM
So much paytience !!!
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