Replies to post #164683 on Vivos Inc (RDGL)

[King23]

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[SC8]

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

If FDA suggests critical must do work for them to seriously consider an IDE application, and results of that work haven't been submitted, has any progress been made?

In short, FDA can't consider what hasn't been submitted. That's the reality of situation.