Ianbec...I feel we are in the home stretch as well. The Images and the radiologist report is the last information the reviewer looks at to come to a decision, and we know these reports are glowing. It is called performance data. It is the 9th and final question on the FDA road map!!
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!
I don't think other companies promote their correspondence with the FDA as much as IMGG does. That is what has kept most people in so long is that the FDA decision is always right around the corner. Well if it's always right around the corner then we should find out how big the corner is. I can't believe that I'm closing in on a year for this quick trade. The only thing we ever seem to hear back from the FDA is that the submission is missing something or they have to remove something. I'm sure it will get there, but when is the big question. I plan on making my money back but I don't think it will be by waiting for approval. I think alot of folks know this could take awhile. I'm gonna wait and see what happens next week, but I expect there will be a small upward movement and then a nice big hammer to the chops.
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