Vivos Inc (RDGL)

[kayak_wench]

Most important thing I saw in the PR was "We agreed to provide the detailed test plan in another submission and the agency agreed to expedite the schedule for their review. "

Korenko left the meeting without another date from the FDA about when they can return with a detailed test plan. They can't start the experiment until that happens. The FDA best case schedules meeting a month out, it could be more like 3. What is very relevant is they did not schedule it while they were there. Probably because Korenko isn't sure when he can pull that together. They will probably start discussing that with the Mayo Clinic doctors now that the high level test plan as been blessed. What is also key is that Korenko did not give a schedule estimate at all, not even for the part after the detailed test plan is reviewed and accepted by the FDA. Mayo Clinic doctors have to work this test into their schedule. They can't do that until the detailed test plan is approved. By then they could not have an opening until several months down the road. This is not the highest priority for the Mayo Clinic doctors, it will take a back seat to pulling in big revenue for the hospital through patients. Also, Vivos will have to pay the doctors for both the experiment and their contribution to the plan.

But as others said this should be the last test so we just sit and patiently wait. I think it will be 4 months minimum to wrap up and maybe 9. Now that is just my personal opinion based on previous times it took for the FDA to schedule meetings with companies I have invested in. First thing we need is to hear that the detailed test plan is completed and another meeting is scheduled with FDA. That is something I hope we hear about in the next month.

Until then we sit back and wait. The good news is now we know this is the last test until IDE submission so that removes a ton of uncertainty that was holding the stock down.