Without Radiogel IDE approval, RDGL is worthless and dies. That makes it an FDA play, nothing more. Sorry, but IsoPet isn't close to break even, let alone profitable.
We now know why FDA put 4th meeting back on again, and result is further delays, as has been case with the prior meetings. Meetings with FDA mean there are complex issues requiring meeting discussions. When in end game, FDA will cancel meetings as unnecessary. Doesn't look like we're even close to end game here. Sure hope MK doesn't take another year to get FDA a 3rd draft IDE application.
Looks like next stop is major dilution. Sad.
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