Here is something.... http://www.investorvillage.com/mbthread.asp?mb=341&nhValue=180368&nmValue=180408&dValue=1&tid=13135635&showall=1 FDA page. It was apparently designated 9/13 http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=390813 If you want to know what Orphan Designation means: http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm