Orphan Drugs--"Both FDA and EMA grant orphan designation to promote the development of therapies to treat rare diseases. Incentives offered by FDA to companies to develop rare disease therapies include more frequent interaction with the FDA, tax credits related to development costs, waiver of prescription drug user fees for NDA submission, and a 7-year marketing exclusivity period in the U.S. following regulatory approval, and the potential for grant funding for clinical trial costs."
I wonder if RCPI has looked into Anatabloc as applied to 'orphan drugs'? Might help with their schedule and finances.(?)
This excerpt from: FDA and EMA Grant Orphan Designation to Xeris Pharmaceuticals' Soluble Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Patients
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