WoW: If approved by the FDA, PGLG could be the first FDA-approved treatment for pediatric patients with sickle cell disease, and the first new treatment in nearly 20 years for adult patients. Emmaus' PGLG therapy has received Orphan Drug designation in the U.S., Orphan Medicinal Product designation in the EU and Fast Track designation from the FDA. Emmaus also plans to submit a marketing authorization application to the European Medicines Agency.