Vivos Inc (RDGL)

[SC8]

Please, you know it's on RDGL website in their update after 1st pre-submission meeting with FDA: https://www.globenewswire.com/en/news-release/2021/12/02/2345196/0/en/Vivos-Inc-Obtains-Feedback-from-the-FDA-on-Clinical-Testing-of-RadioGel.html

You also know FDA doesn't ask for anything in these pre-submission discussions. They make suggestions on what would make for a strong IDE application. From the update: "FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo protocol for clinical testing, and the need for some additional specific testing."