Vivos Inc (RDGL)

[SC8]

But it is a requirement for human trials. There is no way FDA will approve human trials conducted by unqualified physicians. There is no comparable product to Radiogel. At moment there are no physicians fully trained to use Radiogel.

If RDGL submits IDE application before successfully manufacturing Radiogel to FDA standards and training the Mayo physicians, best they can get is a conditional IDE approval if not an outright rejection of application. Pretty sad after 8 years, MK is still messing with basic stuff like this and not ready for human trials.

The guy is a gross incompetent.