Replies to post #163140 on Vivos Inc (RDGL)

[SC8]

Facts? From April 2023 RDGL downdate:

"FDA Pre-Submission Meeting
We presented to the FDA the case for the urgent benefit of RadioGel™ Precision Radionuclide Therapy (PRnT) over the current standard of care, our proposed path forward to respond to their new comments on genotoxicity........................."

The genotoxicity omission was flagged by FDA during review of 2nd draft IDE application submitted over a year after 1st draft. RDGL already had the FDA comments before the meeting. There was no surprise suggestion for genotoxicity testing at the April meeting. MK came to meeting prepared with his path forward on the genotoxicity omission that FDA had already flagged.

Had MK responded to FDA comments on 1st draft in a timely fashion, the omission could have been flagged much earlier and this major delay could have been avoided entirely. Instead, MK exacerbated the delay by dragging his feet. So here we are still waiting on genotoxicity testing that hasn't even started.

Again, I cite facts from RDGL updates (or in this case a downdate) and draw obvious conclusions.