These data reinforce a prior study where this gene therapy approach was shown to successfully restore dystrophin in diseased individual muscle cells acquired from biopsies of DMD sufferers. Together, these results establish a robust basis for AMT’s therapeutic method of DMD. On October 8, 2009 the European Medications Evaluation Agency granted Orphan Drug Designation to AMT’s gene therapy product AMT-080 for the treating DMD. This entitles AMT to a decade of marketplace exclusivity to treat DMD in Europe following marketing approval for AMT-080, provided that this product candidate is the initial such approved new medication with a significant medical advantage.The U.S. Food and Drug Administration provides limited authority over health supplements. Normally it takes action if something on the marketplace is found to be unsafe, for example. But that operational system, Cohen said, depends on doctors and customers to submit reports of harm from products. Also, supplement labels need not carry information about unwanted effects. Nor is there any warranty that the product provides the ingredients detailed on the label – – and only those substances, Cohen added. In a report published this year, he and his colleagues discovered that nearly twelve supplements marketed for weight loss were spiked with an amphetamine-like substance called BMPEA.