Replies to post #173866 on Vivos Inc (RDGL)

[Truthsocial]

Upon IDE approval
Mayo training and their IRB approval are already completed

IMO we need IDE SUBMISSION AND APPROVAL...

[wrinklesobw]

If you’re talking about human trials.

Depends if ide doesn’t get submitted until end of June then possibly a full 30 days for FDA to look at and decide if it passes.
My opinion this will only take 10-15 days at most. If FDA approves IDE

I’m guessing around 30-60days after IDE approval they will start human trials. So at the earliest August/September for human trials to begin. Granted I have no clue what the Mayo will have to do before they can start trials. Training has already been completed to use Radiogel which is required by the FDA I believe.

As for human market figure 12-18 months after human trials start.

My opinion of course. Could happen sooner or later

[wrinklesobw]

What will also determine the time frame is how many participants the FDA will require which should only be between 10-15 patients. But more along the lines of how fast the Mayo Clinic can find the required amount of patients.