Vivos Inc (RDGL)

[SC8]

First, Radiogel has to kill healthy tissue somewhat beyond tumor margins, or the treatment is for naught. So your "no exposure to healthy cells" is nonsense. And again, in most cases should Radiogel be approved, chemo will be part of the treatment, so safety comparisons to chemo are irrelevant. Moreover, you're making same error MK often does of making containment and safety claims for Radiogel without any data to support those claims; hence why the FDA suggested the controlled and monitors rabbit testing, that MK has failed to date to complete and submit to FDA.

The reason FDA suggested genotoxicity testing for Radiogel and didn't for other brachytherapies is obvious: Radiogel is targeting early cancers when a patient has much more to lose vs. brachytherapies targeting late stage cancers to extend life somewhat when the patient has almost nothing to lose. Since FDA flagged the genotoxicity omission upon reviewing MK's years late response to comments from first meeting in Nov. 2021, in all likelihood, FDA asked about genotoxicity in comments before 1st meeting and was dissatisfied with MK's years late response.