Vivos Inc (RDGL)

[Tcsxyz]

De Novo

This failed twice with ADMD (then) and failed previously with a company that had it before ADMD had it. For a total FDA denial overall of 3 times

It received a 22 page denial letter along with Dr Fisher in on the process.

There is no De Novo that has been granted to date that is radioactive that gets injected into the body

There is also no De Novo that has ever been granted that gets injected into humans that has any source of half life.

This will not receive a De Novo. This is required for clinical trials as it stated in the denial letter.

Hence why they decided to go the pet route