Vivos Inc (RDGL)

[Musical Shares]

I did. I don't deny that. Is that what you are looking for when you keep posting it?

I compared RadioGel to an asthma inhaler. Anyone can go back through my posts and see that. And they can read what I wrote in the context it was intended.

Again, when I showed up here you (among others) didn't know RadioGel was a drug-device combo. And you even went as far as to say "not every product that has a drug and a device is a drug-device combo." I gave an example to match. And then I pointed out in the SEC filing:

The FDA requested that the Company file a request for designation with the Office of Combination Products (RFD130051)

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001449349/000149315223006366/form10-k.htm



And then there is this below. Something that further explains the situation.

Consider a drug formulated with a polymer that modifies release. The drug product is packaged and shipped as a solid powder. When water is added, the polymer forms a gel that allows for direction application to the affected area. The release rate is controlled through physical means and is not impacted by physiological conditions. Is this a drug product or drug-device combination product?

The above-referenced FDA guidance offers insight. Sections B(ii-iii) in the drug vs. device product classification section state that for a medical product to be a device, it must not achieve its intended purpose through chemical action within or on the body and must not depend upon metabolization.

In the case above, the polymer is used to control release through physical deposition and does not interact with the patient directly. Excipients that modify the release of an API are not typically considered devices. However, because it forms a polymeric gel that physically controls release, the component would meet the definition of a device, and the described product would be classified as a combination product.

https://premier-research.com/perspectives/do-you-have-a-combination-product-and-is-it-drug-led-or-device-led-early-regulatory-insights/