On December 4th, 2017, GW Pharmaceuticals plc. (NASDAQ:GWPH) filed its financial results for the fourth quarter and year-ended 30 September 2017 with the SEC.
“With the Epidiolex NDA for Dravet syndrome and Lennox-Gastaut syndrome submitted, we have entered a very exciting period for GW and look forward to working with the FDA to support its review process. With a decision on the NDA anticipated in mid 2018, we believe we are making excellent progress with preparations to ensure a highly successful US launch if Epidiolex is approved,” stated Justin Gover, GW’s Chief Executive Officer. “We also expect to submit a European regulatory application for Epidiolex for these indications in late 2017 and are now building a European commercial presence to prepare for a potential future launch. During 2017, a substantial body of positive clinical data on Epidiolex was published and presented, including a landmark publication in The New England Journal of Medicine, as well as a wide range of important data presentations and posters at the American Academy of Neurology and American Epilepsy Society annual meetings. Beyond Epidiolex, as a world leader in the field of cannabinoid science, we continue to advance a number of additional exciting pipeline clinical programs.”
See the full 20-F filing here.
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