Replies to post #157197 on Vivos Inc (RDGL)

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Again, these are pre-submission discussions. FDA only makes suggestions for the IDE application. They don't formally request anything. Now obviously, if one doesn't comply with a suggestion, the odds of approval drop accordingly. So one could argue it's a distinction without a difference. Hence why MK's resistance and foot dragging was nuts. Time is $.

Also it's been clear from updates the "new" reviewers were at first meeting. So it's a mystery what was meant by new, new from when? My guess is new from the failed BDD application. Apparently MK is clueless that he burn a bridge with the lead reviewer in that case.

From https://www.radiogel.com/2022/05/24/us-fda-meeting-05-20-22-summary/:
"Eight of the eleven FDA staff that reviewed our original IDE submission were new and not familiar with RadioGel™." Clearly that refers to first meeting.