Replies to post #121591 on Vivos Inc (RDGL)

[overunder]

Radiogel is not a drug. I don't believe there are any phase type trials for a medical device classification.

Vivos is currently gathering data for a de novo decision by the FDA, and if approved as a class 2 device, I believe they could begin treatment via trials immediately. Well, obviously after establishing proper training and followup protocols etc.

This is from their latest 10K Bold by me As per the 10K below is also covered by foward looking statements.

..............The Company believes that its submissions to the FDA to date have addressed all the FDA staff’s feedback over the past four years. Of particular importance, the Company has provided corresponding supporting data for proposed future testing of RadioGel™ to address any remaining questions raised by the FDA. We believe, although no assurances can be given, that the clinical testing modifications presented to the FDA in August 2017 will result in a de novo reclassification for RadioGel™ by the FDA....................


Here is the link to latest 10K. The regulatory history of radiogel starts on page 2, about midway down.

10-K