What the FDA roadmap tell us is that we will be approved!!! All that matters is that we have made it to that magic last number. To get there we had to pass all the questions regarding NSE that the reviewer had to answer. If we did not, we would have been sent an NSE letter and never made it to the perfomance data question. And we did , with flying colors. Performance data is the last question for the reviewer to address and the radiologist performance report will send the dominion on to a substantially equivalent determination!!!
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