Vivos Inc (RDGL)

[SC8]

Skipping steps as usual. The results reports then have to go through 3rd party review before submission to FDA. And if 3rd party reviewer flags any items...........? And how many times in last year has MK said testing was complete and results write up is in progress? Does anyone really know what's going on when CEO can't be believed?

Then RDGL has to make Radiogel to FDA standards and have Mayo docs certified before IDE submission, or best that can be hope for is a condition approval, aka more meetings with FDA until RDGL is ready, and Radiogel is deemed safe and effective enough, for human trials, which brings up another of MK's repeated lies. In Dec. he claimed FDA had already made that determination. Now in March he says FDA has yet to do so. Again, the guy has no credibility.

In any case, after all this time, a conditional IDE approval would be a major setback with no end in sight.