No speculation. Per RDGL, MK hasn't submitted rabbit results completed months ago and hasn't started genotoxicity testing omission FDA flagged months ago. At a minimum, those have to be completed before IDE submission. Here we are almost two years since MK said RDGL would submit IDE application, still waiting with no end in sight, no path forward, no timetable and uncertain cash situation. Yet, MK continues to waste time and money on trying to expand hopeless IsoPet long after proving RDGL just doesn't have the resources to do so.
All facts.
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