Vivos Inc (RDGL)

[SC8]

Please, genotoxicity omission was flagged well before the April meeting. It was flagged in review of 2nd draft IDE application that MK took over a year to submit to FDA. Per prior updates, we know FDA gave RDGL their comments on 2nd draft and said no meeting needed. MK dragged his feet and had April meeting to discuss genotoxicity testing further instead of getting unto the missing testing, just as he did before with the rabbit testing FDA suggested from getgo.

And here we are still waiting with no end in sight. Can anyone confirm if genotoxicity test plan was indeed even submitted this week let alone discussed at meeting with FDA? And when does testing start? How long before results written up and submitted?