Vivos Inc (RDGL)

[HoneyBager]

You don’t submit an IDE until after the presubmission meetings were discussed. Therefore when the first line of the press release says they submitted the ide it means they already had the presubmission meeting hence the term “presubmission”

-Rdgl - contacts FDA about efs ide
-Rdgl has presubmission meetings
-FDA gives rdgl direct support of what they need rdgl to do
-Rdgl does it and submits ide
-Now they both rdgl and fda stay in contact throughout the process