This Recent Federal Law Could Help GW Pharma's Epidiolex

Source: GW Pharma
Source: GW Pharma

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.

Get ahead of the crowd by signing up for 420 Investor, the largest & most comprehensive premium subscription service for cannabis traders and investors since 2013.

Exclusive article by Alan Brochstein, CFA
Alan Brochstein, CFA
Based in Houston, Alan leverages his experience as founder of online communities 420 Investor, the first and still largest due diligence platform focused on the publicly-traded stocks in the cannabis industry. With his extensive network in the cannabis community, Alan continues to find new ways to connect the industry and facilitate its sustainable growth. At New Cannabis Ventures, he is responsible for content development and strategic alliances. Before shifting his focus to the cannabis industry in early 2013, Alan, who began his career on Wall Street in 1986, worked as an independent research analyst following over two decades in research and portfolio management. A prolific writer, with over 650 articles published since 2007 at Seeking Alpha, where he has 70,000 followers, Alan is a frequent speaker at industry conferences and a frequent source to the media, including the NY Times, the Wall Street Journal, Fox Business, and Bloomberg TV. Contact Alan: Twitter | Facebook | LinkedIn | Email

Get Our Sunday Newsletter