European regulation No 141/2000 says that a medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: a) that it is intended for the diagnosis, prevention, or treatment of a life threatening or chronically debilitating condition that affects ≤5 in 10 000 persons in the EU when the application is made or for which marketing is unlikely to generate sufficient return on investment without incentives b) And that no satisfactory method of diagnosis,...