Vivos Inc (RDGL)

[SC8]

Just one reason FDA will not approve Radiogel human trials? Here are a few:

First RDGL has to ask them to via an IDE application. We have no idea if/when RDGL will submit application, just that they are in discussions with FDA to put together best application possible. The discussions don’t necessarily conclude with FDA suggesting IDE submission.

Per today's update, rabbit tumor containment model is far more challenging than MK originally realized. Sounds like best possible rabbit tumor size, if achievable, will be on small end of what MK was hoping for and will take considerable time to grow these tumors in any case. If this drags on too long, RDGL may lack resources to even get to IDE submission. Even if another offering possible to raise $ without IDE at least submitted, the dilution will be ugly.

Likewise odds of successful Radiogel containment within rabbit tumor are now a bigger unknown given today’s revelation both RDGL and JHU have little experience with these rabbit tumors.

Hence, my guestimate odds of only 50/50 chance at this point. Hope I’m wrong. Again, if I were MK, I'd try to talk FDA into a different animal model more suitable for a Radiogel demonstration, while being prepared to go with the rabbits if FDA insists.