Vivos Inc (RDGL)

[SC8]

Pretty sure gotta schedule meeting with FDA to get on review docket even though FDA may later cancel meeting if matter settled beforehand. I recall seeing something about pre-IDE submission discussion process with FDA that when applicant submits anything during process for FDA review/comments/ suggestions, etc. that the applicant schedules a meeting with FDA for discussion and FDA will cancel meeting if the matter is resolved beforehand. In other words, I don't think RDGL, upon submitting detailed animal test plan to FDA, gets out of scheduling the third meeting mentioned in June 28 tweet, but FDA may sign off on plan or recommend changes beforehand and cancel meeting because no further discussion is needed. Likewise when animal results are submitted to FDA, a meeting will be scheduled to discuss, and best possible news is FDA cancels meeting and says go ahead and submit IDE application.