Vivos Inc (RDGL)

[HMONNY]

It was Not Rejected, IT was given a (NSE) non substantial equivalence

ADMD resubmitted with a better argument that in fact it is as Y-90 is a common treatment that has been approved with the FDA as early as 2002.

Only difference is the delivery method & the dissolvable RadioGel which has since been Patented.

ADMD had 1 in person meeting directly with the FDA since & multiple conversations as to which was the most feasible way to get the product in the market.

Hence the delay in resubmitting.

Approval Rate very high / Positive feed back even HIGHER.

IMO ADMD$