Additional Relevant Details The U.S. Food and Drug Administration has granted Orphan Drug Designation for cannabidiol for the treatment of Tuberous Sclerosis Complex. TSC is a rare genetic disorder, the most common symptom of which is epilepsy. Epilepsy occurs in around 80-90% of TSC patients and is a significant cause of morbidity and mortality. TSC is the third orphan indication that GW is targeting within its Epidiolex (CBD) clinical development program, which includes four Phase 3 pivotal trials in Dravet syndrome and Lennox-Gastaut syndrome, both rare and catastrophic forms of childhood-onset epilepsy. On April 11, 2016, GW announced it has commenced a Phase 3 clinical trial of Epidiolex as an adjunctive therapy for the treatment of seizures associated with TSC.