Replies to post #166461 on Vivos Inc (RDGL)

[Cameron12221]

I'd think the FDA would want them to wait to submit the IDE until the testing results are in or why bother asking for it.

The only thing I could guess in your thought is if the FDA was completely comfortable with previous data on this subject, but wanted them to submit testing for IDE submission technical reasons.

I do believe there is a lot of data on this already, but again I'm sure they have to do it for technical reasons. If anything this will help create a stronger IDE than without if the data comes back positive.

[SC8]

In that case, FDA has already so informed RDGLvia comments. And yes, that would be great news.