Vivos Inc (RDGL)

[User-499230]

I could be completely wrong but in my opinion the Sprint Discussions on the five topics began on 13 September which puts the 45 day Sprint Discussions deadline to reach an agreement on all issues between Vivos and the FDA review team at 28 October when Dr. Korenko bought shares. Vivos' update that states the Sprint Discussions would be "scheduled over the next six weeks beginning [13 September]" likely indicates that the FDA review team is adhering to the 45 day Sprint Discussions deadline and the rules of the Sprint Discussions in general. Dr. Korenko probably bought additional shares on 28 October to possibly signal to shareholders that while there is a disagreement between Vivos and the FDA review team the Sprint Discussion process IS working the way that the Sprint Discussion process is supposed to. Anyway, again, it seems like an agreement between Vivos and the FDA review team was not reached within the given 45 day timeframe on at least three topics. At this point the matter has likely been elevated and Vivos is likely engaging with FDA senior management to support a quick resolution IF a resolution hasn't already been reached between Vivos and the FDA senior management. The FDA review team and the FDA senior management HAVE to prioritize and make time for Vivos as Vivos attained the much coveted Breakthrough Device Designation. Hopefully this month we receive news that everything has been resolved and Vivos is tweaking the IDE application to resubmit. Fingers crossed for NO additional testing which does not seem like it right now. Again, just my take on the situation. I could be completely wrong.