Vivos Inc (RDGL)

[SC8]

Don't know if or when FDA suggested rabbits, but likely at first meeting. RDGL came to second meeting with outline of test plan and FDA said what they expected in the detailed test plan. We know per updates after first meeting, that more animal tests might be needed, so clear FDA was prodding them from the get-go that submissions at first meeting were unlikely to going to cut it in a successful IDE application.