Nephros Inc (NEPH)

[docmts2]

I've just begun doing DD on Nephros' hemodialysis system and I find it to be very promising. The company claims that the two stage filter design of the OLpur MD 190 achieves superior urea clearance of post-dilution hemodiafiltration, while offering unsurpassed clearance of toxins in the middle-molecule range. Well, this makes sense and the fact that the product is already being used successfully in other parts of the world supports its viability. However, there are aspects of the 510k submission that appear to be troubling and I'm looking for clarification. The company claims that long-term studies have demonstrated the value and efficacy of hemodiafiltration over hemodialysis and yet they have no current case studies to support the superiority of the product. Also, because this is a novel two stage filter design, it appears that a PMA submission is more appropriate than a 510k and that's why the 510k application was denied.

I've found that most biotech products like this will have at least one investor on a message board who's long term DD is so thorough and precise that this person is all but an expert on the product and/or the product's FDA application process. If there is such a person on this board, I'd be interested in hearing his or her take on why the application was denied, why a 510k seems more appropriate than a PMA application and where he or she thinks the product application process with the FDA will go from here. Will this product eventually get approve and if so, by what pathway and why?

I don't care if its by 510K or PMA and I don't care how long it takes. If the product its truly viable, which other medical communities around the world believe it is, it should get approve here in the U.S. eventually. To not allow a product to compete in this market when it has proven that it certainly can is un-American and if this product truly has what it takes, its only a matter of time. If there's a knowledgeable investor on this board who can bring good DD to the table to address the questions above, I'm very interested in hearing what he or she has to say.

Thanks in advance.

Doc