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GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) Updates On Operational Highlights In Q4 2017

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GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) issued financial report for the fourth quarter ended September 30, 2017, wherein it also highlighted the operational achievements for the respective quarter. Justin Gover, the CEO, expressed that with the Epidiolex NDA for Lennox-Gastaut syndrome and Dravet syndrome submitted, they have entered an extremely thrilling period for company and look forward to coordinate with the FDA to assist in the review process.

The details

Gover stated that with a decision anticipated in mid-2018, they consider they are making remarkable progress with preparations to record a highly successful U.S. release if Epidiolex is approved. They also anticipate to present a European regulatory filing for Epidiolex for these indications this year itself and are now establishing a European commercial presence to get ready for a prospective future launch.

In this year, a substantial body of promising clinical data on Epidiolex was presented and published, including report in the New England Journal of Medicine, and a broad range of vital data posters and presentations at the American Epilepsy Society and American Academy of Neurology yearly meetings. Beyond Epidiolex, as a global pioneer in the segment of cannabinoid science, GW Pharmaceuticals continue to grow several additional thrilling pipeline clinical programs.

During the report quarter, New Drug Application presented to the FDA for both LGS and Dravet syndrome indications. NDA decision expected at close of December 2017. If priority review designation allowed, PDUFA date anticipated mid 2018 while European regulatory filing projected in this year itself. Phase III Dravet syndrome study data issued in the New England Journal of Medicine. The phase III LGS study accepted by a leading journal and publication anticipated in early 2018. More than 25 posters showcased at American Epilepsy Society Yearly Meeting pertaining to Epidiolex. Phase 3 study in TSC ongoing with report anticipated in H2 2018.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of MMJReporter.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure

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