Vivos Inc (RDGL)

[SC8]

Just citing facts from RDGL updates (only downdates so far this year), and those facts don't look good. Situation is what it is. Wish it was better. It's not. Situation doesn't look good.

As far as what FDA reviewers know, they can only know what RDGL submits. We know MK hasn't submitted the critical rabbit results and may submit a genotoxicity test plan this week for FDA to consider and approve. Then more testing will have to be done, results submitted, etc. So appears FDA knows no more than we do. 2023 more than half gone now, and given MK's continued distraction with hopeless IsoPet, it appears very unlikely Radiogel IDE application for human trials will be submitted this year.

Big unknown now is does RDGL have the cash to get through IDE approval? No one at RDGL can intelligently answer that until there's a clear path forward and timetable to get there.