Vivos Inc (RDGL)

[SC8]

Kind of obvious the degree of seed migration problem wasn't known pre-approval, hence why Radiogel is being asked to verify containment and leak potential, etc to include in IDE. Now FDA knows and holds new market entrants to higher standard. To date, RDGL has provided no such containment data. As far as why seed treatments are still available, obviously there are no alternatives in some situations. Radiogel isn't even a candidate yet.

On your other point, Radiogel isn't a replacement for all external radiation treatments.

All this FDA bashing is nuts. RDGL hasn't even submitted an IDE application for FDA to consider, and nothing will happen until they do. Instead, after doing nothing for 8 months post BDD failure, RDGL then entered into a pre-submission discussion process, and instead of sucking it up and doing as FDA suggested, it took two meetings and 8 months before MK accepted he wasn't going to get by doing this on the cheap and needed more data. Now looks like testing might start two years post failed BDD. All delays are on RDGL, not FDA.