Vivos Inc (RDGL)

[Big Al T]

These statements are taken from cold hard fkn facts: (At least now you know)
- The FDA granted Radiogel BREAKTHROUGH DEVICE DESIGNATION for it's HUMAN treatment Radiogel
- The FDA suggested to change their recent IDE Submission to a "Q" Pre-Sub application to allow for additional clarification.
- The FDA allowed RADIOGEL to have 5 meetings (ALREADY COMPLETED) over 6 weeks starting on September 13th, once again COMPLETED.
- The FDA has requested 3 additional meetings to cover information that the company had anticipated would be addressed post approval.

Opinion: I think the FDA has had all of their initial questions addressed over the 5 meetings described above and are asking for some final details to be addressed for an expedited path to Human Clinical Trials.