Vivos Inc (RDGL)

[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.