Vivos Inc (RDGL)

[SC8]

I just read the sentence in question as an intention or forecast to submit a genotoxicity test plan to FDA this week for their review. We know RDGL has to request a meeting at time of submission to get on review docket, at least that's been pattern for the 4X we've already gone through this process. I don't consider that dialogue until RDGL receives the review comments.

In any case, fact is we know nothing until MK confirms the plan has actually been submitted, and looks like he's radio silent until Oct. All we know now is his intention to submit a test plan this week. Bear in mind we're still waiting for the big submission (IDE application) that MK forecast would happen no later than 22 months ago.