Vivos Inc (RDGL)

[SC8]

So what do you think would have happened if MK hadn't withdrew the application before the 30 day consideration period? The fact is FDA would have rejected the application. Whole purpose of the pre-sub program is to avoid things like this; it's just a fact. Likewise it's just a fact MK did not present the written up rabbit results to FDA during pre-sub program before he submitted the IDE application. And why did he have to do more rabbits after lying about completing the study last year? Yes, it's a fact MK is a proven serial liar. And why did it take him most of a year to write up the results? Yes, that is another fact.

Most likely the containment issue remains unresolved and MK tried to put lipstick on a pig.

Only the last sentence in all the above is conjecture based on the facts. Everything else above is fact per the public record.