Vivos Inc (RDGL)

[MilkWai]

I think there's very little more to think about.

Y-90 has been demonstrated to kill tumor cells already with TheraSphere and SIR-Spheres both FDA approved (in 1999 and 2002 respectively). The following things that need to be addressed are

-bio-compatibility of the microsphere (is it toxic to the body? would the matrix react with any other parts of the body to produce side effects?)

-biodegradeability/shelf life (how long is the Y-90 held inside the matrix? 24h? 1week? decades?)

-elimination (how will it be excreted from the body?)

That is probably a really simplified picture (numbers are important), but these are the major areas that ADMD's Radiogel has to tackle. And probably what the FDA is looking for. And it's probably not too difficult to find/make a biocompatible polymer capsule. Look at the stem cell research - they're using PLGA, PLLA, PEG scaffolds in vivo for animal studies already. I'm pretty sure the Radiogel polymer composite is some modification/mixture of these polymers. Or it can be part of the same materials made for the formulation of drugs inside pills. Point being a lot of technology has been developed already and demonstrated to work so there's likely little chance it won't receive FDA approval. It's a matter of whether or not ADMD's scientists and engineers are competent enough to piece it all together. And if somebody is going to drop 5 million dollars for you, it's a good bet that they got it right.

Edit:
This is my evaluation of the technology. I've worked enough in the lab/read enough papers on capsules that it's not particularly difficult to make sufficient matrices. Chitosan, hyaluronic acid, pectin - they've all been used already and are friendly to the body.