Ernie. re the FDA. The FDA approved Omonty for dialysis patients . My wife's Nephrology Dept thought their decision was rushed and decided to wait a year before using it . They wanted to see how the other dialysis clinics did with it . For the first 20,000 treatments the drug worked fine ...then one patient went into shock and died from the drug . Soon after two others also died in reaction to the drug . FDA recalled the drug Co that developed the drug went bankrupt. So yeah ...let them ( the FDA ) take their time Kiwi