Vivos Inc (RDGL)

[Cameron12221]

"proposal/testing/protocol"

Are you planning on submitting the IDE after the genotoxicity (proposal/testing/protocol) testing is finished, or are you staying on the same path?



Our specific plan for the next IDE submission depends on the results of the feedback from the FDA at the next meeting scheduled for September 29, 2023.

Collectively we decided that our approach would be to submit an amendment to the previous IDE. Listing and then addressing all the FDA comments over the last five years, and then providing the answers - sometimes for the second time. This allows us to build on our progress and is the optimum way to communicate since 50% of the FDA reviewers are new.