Vivos Inc (RDGL)

[Musical Shares]

The FDA doesn't revoke BDD's. It's not like they are going to go back in their system and take it away.

What the FDA will do is reject the IDE. Which, it did.

The BDD is simply for participants who might have a potential breakthrough medical device.

The safety is questionable. It's why it was rejected twice since the BDD. It is also why the FDA made them do another New Zealand rabbit study.

Korenko has updated his "shareholders" on numerous things except for the genotoxicity report.

It makes sense when you think about the sub-clinical doses and never hearing about the second rabbit study the FDA wanted.