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GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) CEO On Q4 2017 Financial Performance

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Justin Gover, the CEO of GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), expressed that at the close of October, the company achieved the goal of completing its Epidiolex NDA filing to the FDA. They anticipate to get the decision from the FDA at day 60, that it around the end of December, pertaining whether the FDA will accept the filing. Currently, they would project to get confirmation of an expedited assessment of the NDA. If so, it would result in a projected PDUFA date in mid-2018.

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The CEO of GW Pharmaceuticals expressed that he wants to thank all of those employees, patients and clinicians that have made such a notable commitment to achieve this advancement milestone. At merely 3.5 years from IND to achievement of the NDA filing, the Epidiolex plan has been fast by any measure. It showcases their response to the grave unmet need in subjects with Dravet syndrome and Lennox-Gastaut Syndrome.

Gover added that he is also proud of this year, their initial Phase III study of Epidiolex in subjects with uncontrolled seizures related with Dravet syndrome was issued in the New England Journal of Medicine. Preliminary Lennox-Gastaut Phase III data has recently been approved for publication in a leading journal, which is projected to be published early in the New Year.

This year has been a remarkably busy year across the firm. Their team has not only filed the Epidiolex NDA, but also posted notable growth in manufacture, recorded substantial progress in preparations for the expected launch of Epidiolex in the U.S. and started to establish a European commercial presence. In addition, the firm has continued to advance its portfolio of clinical stage product candidates.

The CEO of GW Pharmaceuticals stated that they anticipate next year to be a transformational year. They are planning for the anticipated approval and release of Epidiolex in the U.S. They understand that the epilepsy community has been expecting these potential events as Dravet Syndrome and Lennox-Gastaut exhibits some of the most tough types of epilepsy to treat.

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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