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GW Pharmaceuticals PLC (NASDAQ:GWPH) Chief Medical Officer On Q4 2017 Results

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GW Pharmaceuticals PLC- ADR

Volker Knappertz, the Chief Medical Officer of GW Pharmaceuticals PLC (NASDAQ:GWPH), expressed that his first priority after coming at company was the full assessment of the Epidiolex NDA, confirming the completeness of the NDA file and that the instance for Epidiolex’s risk and benefit as well as its efficacy and safety profile was compellingly exhibited in a robust filing.

Although, this marks as an orphan drug filing, he considers the filing to be robust and comprehensive including three Phase III efficacy and safety studies with safety data on around 1,400 patients and information from almost 400 patients with over a year of exposure to Epidiolex.

The details

The safety data is supported by what they consider is a comprehensive clinical pharmacology, toxicology and preclinical package, which is boosted by open label data. There are several measures in the NDA review procedure, and he is assured that the team GW Pharmaceutical have in place which comprises a combination of their expert and internal team guidance from external regulatory professionals many of whom have had years of experience at the U.S. FDA, will manage the process and the following interactions skillfully. Knappertz anticipate the FDA to come to the conclusion with respect to the approval of the NDA’s submission by the close of December 2017, 2-months post completion of the rolling submission.

This will mark as the preliminary opportunity for FDA to specify whether they plan to invite an advisory committee meeting, however they are under no commitment to make this decision at that stage. As the Chief Medical Officer of GW Pharmaceutical stated on last quarterly call, there still exists a 50-50 probability of an AdCom and the company is already set for such an eventuality.

In the last trading session, the stock price of GW Pharmaceutical declined more than 2% to close the day at $116.

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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