Replies to post #178188 on Vivos Inc (RDGL)

[Roofus]

IDE approval can still happen in 75 days ….

Or technically 72 days, since it’s already been 3 days since the news of needing to re-do the submission in terms of going in a different route.

45 days to re-submit.
30 days afterwards for IDE to be approved.

[SC8]

How can anyone have any confidence in any MK statement when he's lied so many times about so many things going back years now?

[chemist72]

Agree. Doesn't matter if there was insufficient data included with the IDE OR if the FDA simply ran out of time.

The thing that matters (imo) is that RDGL requested a PreSub filing to discuss matters with the FDA before filing another IDE submission. Most importantly the CEO should know for sure what is going on. But unless someone on the board has an inside source, nobody's opinion on what is going on really matters.

Obviously, everyone can have their own opinion whether it was a lack of data or insufficient time for review, but I believe only the CEO and the FDA know for sure. It should be the CEO's responsibility to inform shareholders what is going on. The FDA also knows, but they aren't talking. lol

my opinions are just that