NEPH had no correspondence from the FDA for 12+ months prior to a NSE ruling? This makes me wonder if they properly submitted their application to begin with. Given the fact that Dean has successfully submitted and received approval for 3 or 4 510Ks with the longest taking 9 months is huge. This tells me Deans experience in dealing with the FDA is invaluable. The open lines of communication with the FDA bode well for IMGG which NEPH never had!
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