Replies to post #147453 on Vivos Inc (RDGL)

[SC8]

Bridge already crossed. Sure looks like MK has been dealing with it for some time now, hence why tests like bio-compatibility and containment are having to be repeated. Looks like we're in end game here on that issue. Up side is polymer and process changes are basis of expected patent(s) that may make the now public domain Battelle product inferior if not obsolete. Unresolved issue is when will first patent be in hand for offering buyers to consider in valuing RDGL. But the testing reset with FDA seems to be in end game.

[kayak_wench]

Not sure what completely reset means to you. We don't have much in hand in terms of FDA accomplishments/hurdles overcome. What we do have is a relationship with John Hopkins vet clinic, Mayo Clinic lined up for IDE investigation, IsoPet being used in a few veterinary clinics, dosimetry calculations completed, and a dialog established with the FDA to work toward completing an FDA submission.

If we had just completed animal studies with the old polymer and was told we would have to redo that would be a major bummer. I don't see any of our existing accomplishments being affected by a polymer change (As a heads up to those who police posts, by saying 'I' don't see' it should be clear that I am not stating this as a fact rather it is my personal opinion..). Polymers are well understood, many in fact synthetically created to do a specific thing. Vivos wouldn't of changed to a different one if it negatively impacted performance. If a polymer was changed I believe it would have been done to decrease cost or improve performance. That sort of optimizing of the Radiogel recipe is what will let the company maintain itself as the provider of choice when original patents expire. I suspect such tweaks are needed to use the gel in the microinjection system under development to deliver relatively small volumes with precision.