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Fast Track for Epidiolex

  • The FDA designates GW Pharmaceuticals' (GWPH) cannabidiol product Epidiolex Fast Track for the treatment fo Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. Earlier, the agency designated Epidiolex an Orphan Drug for this indication in addition to Lennox-Gastaut (LGS) syndrome.
  • The company expects to hold a pre-IND meeting with the FDA in the next few months and will conduct two Phase 3 clinical trials in LGS in 2015.
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