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kayak_wench

12/09/23 11:43 AM

#168569 RE: lovethatgreen #168566

I agree that if the FDA doesn't throw up more barriers to submission, a submission of the IDE in March is possible. The report has probably already been partially written up with the initial testing so it shouldn't take more than a month to write the report. We have to allocate about a month to the writing of the report to allow it to be circulated and reviewed by several people....each of those transfers involves sitting on the desk and being ignored for a bit.

Next news we need to hear is a new date for the FDA to review the latest material. It is possible we could get an indication of when they will be ready to request a another meeting in our Jan update (something like we expect to be ready to schedule a review by FDA by end of Jan). We have seen that the FDA can make us wait 2 months or more to even give us feedback. So if we wrap up everything in Dec early Jan and they don't throw anything else a submission in the March timeframe is possible.
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Malibew66

12/09/23 11:46 AM

#168570 RE: lovethatgreen #168566

I remember reading a response on from Vivos, either on twitter or maybe it was in their update, that the additional nine rabbits would be tested next quarter, and clarified, that "next quarter" was meant as 4th of 2023.
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Malibew66

12/09/23 11:48 AM

#168571 RE: lovethatgreen #168566

I'll see if I can find it and post it, but I think you answered the timeline question yourself already.