Vivos Inc (RDGL)

[SC8]

Only opinions that matter here are those of FDA reviewers.

If a tree falls in the woods, and there's no one close enough to hear it, did it make a sound?

If rabbit results critical to IDE application haven't been submitted for FDA pre-submission review and comment, were the rabbit studies completed to satisfaction of FDA reviewers?

Just to throw results into an IDE application without a pre-submission review is a Hail Mary IDE application that could have been submitted several years ago. Only an incompetent would enter into a years long pre-submission program with FDA and then throw caution to the wind at the end.