WEALTH UNIVERSITY

[$heff]

thecon00....w/ regard to NEPH the FDA would have to inform the company and not the public if they have more questions for Nephros. They dont put a date on medical products for this reason unlike drugs where they have to inform the public if they meet the PDUFA date. That is the difference b/w "approval" date (drugs) and "clearance" date (devices). If they miss the PDUFA date like with DDSS then they have to inform the public. NEPH never had to inform the public when they were two weeks late with the 1st approval even though they were 2 wks late and that was a "equivalent" approval. I believe that it will take longer for the H2H to get approved because it is a product that is a first in its class with the FDA. FDA has been stringent on products that are 1st to the market. The DSU filter was two weeks late and all they required was equivalence to another filter on the market. Simple as that. I mentioned that I do not see this getting approved until October. NEPH is a solid solid company and this H2H will get approved eventually! This has nothing to do with the validity of the NEPH product but it is a more in line with a more stringent FDA. Does it mean I know what the FDA is thinking? Absolutely not! The H2H was supposed to be approved on June 30th w/ the DSU filter and only the DSU got approval. The FDA is 1 month late. That means they required a first round of questions regarding the product. Once NEPH answers those questions they have to submit the answers back to the FDA. The FDA will come back usually with a second round of questions until they are satisfied with all aspects of the H2H. This H2H in my opinion will get approved in October or later. My goal is to re-enter NEPH in early October. If I am wrong I will miss a good opportunity for significant gains but I will take my chances while I put money in other plays. Everyone knows my track record with these plays and my thoughts are proving to be true. I know the FDA process as well as anyone which is why I stand strongly by my personal thoughts you asked for. Best, Sheff