Vivos Inc (RDGL)

[SC8]

Containment testing had already been done on prior version and MK has expressed surprise FDA is requesting re-verification. He blamed having to deal with new reviewers not familiar with Radiogel. Anyone who knows anything about FDA would know you can't change a component or process with finished product and still rely on prior tests with a prior version of product. RDGL changed both a component and process in 2021. It's not a matter of reading FDA reviewers minds; these are the rules well known to anyone dealing with FDA. MK is paying a consultant to guide him through this process, and it's very clear that person is clueless.