Replies to post #147477 on Vivos Inc (RDGL)

[SC8]

That's my point. Yes, MK can give update on when he anticipates submitting detailed test plan, but ball will then be in FDA's court and there may be more than one iteration before plan gets green light. Agree we have no idea what expedited means with FDA time wise, we're in Summer vacation season, etc. So MK giving update he may be able to do at moment doesn't yield a timeline.

[Rusty nail]

People keep talking about submitting a plan. According to the meeting of May 20, 2022, and having read the minutes from the meeting. The plan has already been submitted, according to paragraph three, the FDA has already agreed to the plan.

Quote: Since we anticipated this outcome, we have been in detailed discussions with Johns-Hopkins University to perform the animal testing. During the meeting we presented a detailed outline of the proposed testing to obtain interim feedback. The FDA agreed with or outline and provided initial feedback on what they expect to see
in the detailed test plan.

Please correct me if I'm wrong!!!