Replies to post #198860 on 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. 

[LeAcc]

I’ve voiced my thoughts on MK for the last couple of years - I think there are a lot of items the company should be more forthcoming with.

I’ve learned this - the less they tell us, the more they are struggling. Smith is bolstering their submission with independently verified information to satisfy the safety and efficacy profiles, which should have been done years ago. The lack of info regarding the India trials had me digging into the regulatory approval process - check out the nature of academic studies not requiring DCGI approval. The hook is that they cannot use these studies to bolster future approval submissions - I would venture that, as usual, MK bulldozed this route and later found out that he actually can’t legally publish the material results. They then circled back for DCGI approval for an actual clinical study, and lo and behold, India wants more information.

I’d say we’re 6 months - a year away.

[SC8]

Can't say you weren't warned. It's MK's MO. It's who he is. A deceptive, unprofessional, serial lying, conman going back decades now.

By all appearances, RDGL is a scam