Replies to post #177748 on Vivos Inc (RDGL)

[CatfishHunter]

I was advised by the company that 30th day was this past Saturday based on June 28th being day 1. However, as it’s the weekend, they wouldn’t get final response until tomorrow, Monday. Depending on time of notification, may not get official PR until Tuesday or Wednesday. So I wouldn’t be going into panic mode if no news tomorrow, you’ll regret it imo.

[IPSO_FACTO]

"Most likely case is conditional approval as I’m sure there will be a few remaining questions FDA will have on that much info submitted".

So, what facts is this statement based on that led you to conclude that the "most likely case is conditional approval" and that "you're sure"? Can you elaborate on that for the board?

[GetSeriousOK]

IDE "Approval with Conditions" is still Approval and allows the company to proceed with human trials.

Unfortunately, the Great Unwashed OTC "investors" might not understand that "Approval With Conditions" is still Approval. We just have to roll with the punches in the OTC.

"Disapproval" is unlikely here, but even then it's just a delay, IMO, because if the FDA says "Disapproval" now they will eventually approve the IDE after more discussions. The FDA has already put the company through the wringer, especially with that earlier rejection of the Breakthrough Device Designation. Hubris has been punished; the FDA got their pound of flesh; now everyone, including the Mayo Clinic and the FDA, wants human trials to commence.

Ahhhh the OTC.