Vivos Inc (RDGL)

[SC8]

Gotta keep it real.

The consideration period for IDE application is 30 days. That's as expedited as it gets. BDD status, even if true, doesn't speed that. Burden remains with MK to deliver the IDE application. BDD status doesn't expedite that either, as FDA can't submit the application for RDGL.

So even if MK is lying about BDD status, it has no impact on speed of getting Radiogel to human trials. Sadly, MK has made very clear this is his lowest priority.