Replies to post #160184 on Vivos Inc (RDGL)

[lovethatgreen]

Well see , that w be something about something

[SC8]

Unlikely given 4th meeting back on. Issue complex enough to require meeting discussion has come up.

What want to hear from FDA at this point is: Submission looks great. No need for meeting. Go ahead and submit IDE. Or alternatively: No further meetings needed. Go ahead and submit IDE upon completion of animal testing in progress.

To date every RDGL-FDA meeting has resulted in FDA suggesting further pre-submission testing and/or expansion of testing. Maybe this time will be different, but again, best response from FDA now would be no meeting needed.