Vivos Inc (RDGL)

[WALLnut]

IsoPet and RadioGel use the same hydrogel and isototope, it’s one platform, not three different products. The difference is who regulates it: IsoPet’s NRC (animals), RadioGel’s FDA (humans), and India’s DCGI. Same tech, different paperwork.

The FDA absolutely does care about animal data, every device or drug starts with it. Those IsoPet results and GLP dosimetry studies are exactly what support the IDE submission. That’s how it works.

And no, the FDA didn’t “reject” anything. They gave feedback, which happens in every IDE cycle. You fix it, resubmit, move forward — which is exactly what Vivos just did after the Feb meeting.

As for “doesn’t work safely” — the hydrogel’s been tested and proven to stay put and hold the isotope right where it’s needed. That’s the whole point.

Calling it a scam? Nah. You don’t spend years running GLP studies, building NRC supply chains, and setting up India trials just to “string people along.” That’s called doing the work.

Maybe learn the FDA process before labeling it.


$RDGL