Replies to post #170017 on Vivos Inc (RDGL)

[mc73]

Great question...I have no clue. Just sitting here I wouldn't think it is required - I think in the IDE submission we just need to provide enough data to the FDA to prove this technology is safe enough to conduct trials on humans but perhaps the testing protocol with Mayo approval is a helpful plus in our IDE? Maybe someone else can provide a more solid answer to a good question...anyone...Bueller?

[lovethatgreen]

I wouldn't think so but , it's somewhat unfortunate that the company isn't able to be more forth coming w details.

We've all been waiting years for this and they know it as well

[CatfishHunter]

No, training certification is the training for staff conducting the clinical trials to be able to handle and administer radioactive materials.

Just saw this post on X that answers your question.

No. The training certificate is not needed for the IDE submission. Vivos can submit IDE prior to training certification being completed. Training certification is what’s needed to start human clinical trials. Staff doing trials has to be trained and certified to handle…

— Alpha167🇺🇸 (@ClearUTL) January 23, 2024