Vivos Inc (RDGL)

[CatfishHunter]

Agree.  I know many like MK.  Highly educated, PhD, think they’re always the smartest person in the room and know better than everyone else.  I will give MK credit for saving the company, but as for trying to advance Radiogel to clinical human trials himself, he really dropped the ball.  MK should have never gone after DeNovo as well as trying to get RadioGel reclassified.  It was a waste of time and effort and not listening to FDA.  MK thought he knew better than FDA and presented the information himself and it backfired.  Same with going to India to try to pull one over on FDA, thinking he would get faster approval with some human safety data from the initial study. It didn’t happen.  MK should have hired the likes of John Smith for the intial IDE submission and put India on the back burner.   We’d be through phase 1 at Mayo by now.  But we can’t look backwards only forward and it’s all or nothing with IDE submission and approval.  JS has the ball now and odds are high he will make sure a quality IDE package is submitted to FDA and approved.