Vivos Inc (RDGL)

[SC8]

Again, it's not FDA's fault MK takes years to follow-up on suggestions for a strong IDE application. That's all on RDGL. Until RDGL submits an IDE application, there's nothing for FDA to consider. No conspiracy theories needed to explain the delays; MK's incompetence explains it all.

To your other points, Radiogel is a treatment, not a cure. Radiogel employs localized radiation of limited distance to kill a tumor that hasn't spread, so not sure why you're asking "Why are we still using radiation.............". Moreover, it's no surprise FDA would hold an early cancer treatment like Radiogel to a much higher standard than a late stage treatment, hence the genotoxicity concerns. What would be the point of treating a stage 1 tumor just to cause other different cancers nearby?

In any case, RDGL is an FDA play, nothing more. They hold all the cards. It's MK's job to get them what they need to agree to human testing. To date, he hasn't submitted anything they've suggested.