Friday, December 29, 2017 2:43:32 PM
Was wondering if any of you had more information in regards to timeline? From my minimal research it looks like the clinical study of 1000 patients at Thomas Jefferson won't be completed until December 2018, with a study completion set for June 2019 (https://clinicaltrials.gov/ct2/show/NCT03041168). What I am asking are there completed clinical data trials that are sufficient enough to apply for the FDA 510(k) in 2018? Based off my minimal research I don't see a submission with the FDA happening until mid to late 2019 with more time needed to approve. With that being said this tech can be revolutionary, on paper management looks competent, the partnerships especially cannon seem like home runs. I have a few other things I would like to discuss. GLTA.
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