Vivos Inc (RDGL)

[kayak_wench]

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.