Vivos Inc (RDGL)

[SC8]

If MK submits IDE before Mayo docs are certified, FDA at best will issue a conditional approval with a punch list of items that must be completed before human trials. Among those will be docs fully certified and Radiogel manufactured to FDA standards. There is no way FDA will approve human trials until all these issues are resolved. Again, MK is still dealing with very basic issues that competent management would have put to bed years ago.

Hard to see human trials starting this year. It is what it is.