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12/03/22 7:33 AM

#153798 RE: wrinklesobw #153797

IsoPet needs to generate $2.5 million per year profit just to break even. Without funding that IDE approval would bring, RDGL doesn't have the funds or the runway (time left before offering well runs dry) to grow IsoPet business to profitability. In short RDGL dies without Radiogel IDE. That makes IsoPet a distraction at moment. What else is the Doc gonna do? How about focusing on the IDE application that's been neglected for years now. He only just completed a routine IDE requirement. wtf was he doing in 2021 when he twice forecast IDE submission if the routine requirements weren't already done? Answer is nothing; he was distracted by money losing IsoPet. Here we are over a year since it's been clear as day he needed more animal test data, still no closer to getting FDA what they need for a serious IDE application. Instead at each meeting he tries to bully FDA into accepting the data in hand, rather than sucking it up and doing as they advise. Two years and several million $ down toilet because of his foot dragging. His inept management ended up costing far more than had he initially aggressively inquired of FDA (immediately after the failed BDD application) what a serious IDE application needs and just did everything FDA suggested.