Can't bait and switch with FDA. Have to trial product one seeks approval for, not an aged watered down product due to shipping finished Radiogel to India. Safety is far more than containment, and even the containment conclusions are bogus given the low Y90 content. Until RDGL has operations in India, this whole thing is a cash toilet distraction.
Bigger question is can RDGL raise the needed funds to start-up in India? Or maybe they go back the the two pack product they had before MK's "improvements" and have the Y90 part toll manufactured in India? That of course would mean again starting over with FDA.
Again, can't bait and switch with FDA. Have to trial the product one seeks to market.