Replies to post #166186 on Vivos Inc (RDGL)

[chereb19]

the MAYO Clinic knew this was the correct approach. That's why they join the Doc when he attends FDA meetings.

[wrinklesobw]

He forgets that’s also when the bdd fda review team suggested that the doctor goes through the EFS IDE program which the doctor took that advice because it increased the approval chances to 75-80%.

The doctor also said that going this route would take more time because the fda would be holding their hand. But some people forget this.

[SC8]

Again, per MK, he plans on submission without a pre-sub review of rabbit results. So, no FDA approval of human trials is nowhere near a sure thing. I have no idea why someone would spend over two years in a pre-sub program only to throw caution to wind at end, but that's his plan. We have it in writing.

Facts are facts.