Replies to post #162921 on Vivos Inc (RDGL)

[SC8]

Apples and oranges. TheraSphere is targeted towards late stage cancer life extension. Radiogel is targeted for early stage 1 cancers. Of course FDA will hold an early cancer treatment like Radiogel to a much higher standard regarding collateral damage vs. a late stage treatment.

In any case, FDA flagged this months ago reviewing 2nd draft IDE that MK took over a year to submit. And now RDGL doesn't even have a path forward yet because of MK's gross incompetence and continued IsoPet distractions.

[chereb19]

So inline with what Vivos have commented.

There is a chance that Genotoxicity isn't required for the IDE.

Any other thoughts on where Vivos are right now ?

[Cameron12221]

To my understanding, the FDA's view is TheraSphere is considered safely contained as it's permanently in the body.

Their concern is that Radiogelbreaks down in the KREBS cycle and eliminated from the body. They want to ensure no residue will remain in the body.

Kinda funny.