Vivos Inc (RDGL)

[SC8]

Just citing the facts. Are you claiming FDA will approve Radiogel human trials without RDGL even asking them to do so?

FDA can only consider what is submitted and RDGL has to submit an IDE application for human trials with the data FDA has suggested since 2021 for FDA to consider. Once submitted, the consideration period is 30 days. FDA may then approve human trials, conditionally approve with a list of items that must be completed to FDA satisfaction beforehand, or they may outright reject the application.

To date, per his own updates, MK has failed to submit any of that data FDA suggested, let alone submit the completed IDE application.

All facts.