Vivos Inc (RDGL)

[SC8]

Gotta keep it real.

Can't get IDE approval for human trials unless MK submits an IDE application, which brings up another of his lies. He said he was going to submit that application no later than 90-120 days after May 24, 2021. That was three years ago and he never withdrew that forecast. The guy has no credibility.

Moreover, if he submits now, best that can be hoped for is a conditional approval, meaning more meetings with FDA before approval. Per MK, RDGL can't even make Radiogel to FDA standards yet and the Mayo docs aren't yet certified to use Radiogel, etc. Hard to see Radiogel getting to human trials this year.

I don't know what BSD is. Regarding MK's claim of BDD status for Radiogel, we now know it is of no consequence for getting Radiogel to human trials, and that's all that matters now. Again, I don't even try to parse the truth from lies once someone is a confirmed liar, and MK is a confirmed liar. Moreover, even if BDD claim is true, MK also claimed in same Dec. 2024 PR that FDA had determined Radiogel is safe and effective. Now he says otherwise. So we now know he's lying about that too.