Vivos Inc (RDGL)

[SC8]

How do we know FDA added anything? MK took over a year to respond to FDA comments from Nov. 2021 on 1st draft IDE application. Perhaps some reviewers were dissatisfied with his genotoxicity responses in 2nd draft reviewed before 4th meeting last April?

Likewise, FDA can't review and comment on what hasn't been submitted. Per RDGL to date, MK has yet to submit the critical controlled animal testing FDA suggested almost two years ago that MK says was completed several months ago.