GW Pharmaceuticals (NASDAQ: GWPH) reported its fiscal year-end results today and held a conference call after the market closed. One of the more interesting parts of the prepared remarks involved the discussion of how H.R. 639 (Improving Regulatory Transparency for New Medical Therapies Act) takes away some uncertainty regarding the timing of bringing Epidiolex, its cannabis-derived treatment for pharmacoresistant epilepsy in children, including rare forms such as Dravet Syndrome and Lennox-Gastaut Syndrome.
H.R. 639, signed into law on November 25th, caps the amount of time given to the DOJ (the DEA) for rescheduling a controlled substance following FDA approval of a drug at 90 days. Additionally, the seven-year period of exclusivity for Epidiolex due to its “orphan” designation would begin upon rescheduling rather than upon FDA approval. The new law, then, removes some uncertainty regarding a long delay should Epidiolex gain FDA approval.
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