Vivos Inc (RDGL)

[SparksEE]

I was the lead developer for a company that developed an electronic control system for what ended up being a FDA class 2 510(k) device (this was between 1995-1998). When it came time to "validate" the hardware/firmware (ie test & provide documentation that the device did what what was intended) I also ran the validation testing/documentation process. What it "seemed" to me was that the the process was intentionally tedious, difficult, & lengthily.. My thought at the time was this was a way the FDA could separate a company that was capable & determined, versus a company that was not.. Putting a company through a validation ringer uncovers weaknesses in structure. The reason I'm sharing this is that I feel Dr. K's team is as knowledgeable & dedicated as they come. My take is that the Vivos/Mayo combination is not a weak link here, and that they have the expertise/experience & determination to see it through. That's what I think is going to make the difference. It's the FDA's job to make it difficult, and corruption aside (as I have no insight about that) Dr. K's team is up to the job. That is what makes me feel we have a really good chance for success here. This feels like the Last Leg!!