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GW Pharma Announces Publication of It’s Groundbreaking Epidiolex Study

May 25, 2017 • 12:14 PM EDT
4 MIN READ  •  By Michael Berger
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After the New England Journal of Medicine published the results of GW Pharmaceuticals’ (GWPH) Phase 3 study of Epidiolex, more people will know that cannabis does have medical benefits and should not a Schedule I substance.

Epidiolex is GW’s lead product candidate and has proven to be an effective treatment for epilepsy. Epidiolex is a liquid formulation of purified, plant-derived cannabidiol (CBD), which is being studied for the treatment of rare, severe pediatric-onset epilepsy disorders.

A Treatment with Massive Potential

Epidiolex has massive potential since there are currently no FDA approved treatments for Dravet syndrome, a rare form of epilepsy associated with a high mortality rate and significant developmental delays. GW’s study provided results that represent the only well-controlled clinical evaluation of a cannabinoid medication for this condition.

GW’s new drug application (NDA) for Epidiolex is expected and on track to be submitted to the FDA in the middle of 2017. The submission of this application will be a major milestone for the company and should be a catalyst for the stock.

A Highly Successful Study

The Phase 3 study randomized 120 patients and Epidiolex or a placebo was added to the patient’s current anti-epileptic treatment regimen. The average age of trial participants was 10 years and 30% of patients were less than 6 years of age. The patients involved in this study were taking approx. 3 anti-epileptic drugs and had previously tried and failed with 4+ other drugs.

The primary efficacy endpoint was a comparison between Epidiolex and placebo measuring the percentage change in the monthly frequency of convulsive seizures during the treatment period compared with the baseline observation period.

Patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%. The difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period. The proportion of patients who had a 50% or better reduction in convulsive seizure frequency was 43% with Epidiolex and 27% with the placebo.

The study provided incredible results and 62% of patients treated with Epidiolex saw an improvement in overall condition, significantly higher than the 34% from the placebo group. The results also showed that more patients became seizure-free on Epidiolex than placebo and total monthly seizure count was significantly reduced with Epidiolex

Outlook is Bright

GW is changing the landscape of the biotech industry. The company already sells a cannabis-derived treatment for multiple sclerosis is 27 countries and it has by far, the most advanced pipeline of cannabis-derived products in its pipeline.

We are favorable on GW Pharmaceuticals due its extensive pipeline of products in advanced stages of FDA testing, its balance sheet which is strong enough to support the cost of clinical trials, its impressive Wall Street coverage, and the $390 acquisition price placed on the company by Goldman Sachs.



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Important Investor Disclosures 

This report was authored by and is property of Mushroomstocks.  All information and data relied upon in drafting this report is publicly available.  The author believes and considers its sources to be reliable, but does not guarantee the accuracy or completeness of any information contained in this report.  Any and all information, data, analyses and opinions are provided for informational purposes only and is not intended, in any manner, as investment advice.  Any projections or other information generated by Mushroomstocks regarding the likelihood of various investment outcomes are hypothetical in nature, do not reflect actual investment results, and are not guarantees of future results.  None of the material contained in this report is intended as a solution or offer to sell or purchase a specific stock or any other investment.  This report is not directed to, or intended for distribution or use by, any person or entity that is a citizen, resident or located in any municipality, state, country or other jurisdiction where the distribution, publication, availability, or use of this report is contrary to any governing law or regulation.  The securities discussed in this report may not be eligible for purchase and/or sale in certain jurisdictions or by particular individuals.  It is important that you check any and all governing laws and/or regulations that may be applicable in your jurisdiction.  Investing in securities of issuers organized outside of the United States, including ADRs, entail certain risks.  The securities of non-United States issuers may not be registered with, nor be subject to the reporting requirements of the United States Securities and Exchange Commission.  Please contact a Financial Advisor for professional advice regarding any and all securities investments.  This report is intended for informational purposes only. 

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Authored By

Michael Berger

Michael Berger is Managing Partner of StoneBridge Partners, LLC and Founder of Prior to entering the cannabis industry, Michael was an Equity Research Analyst at Raymond James Financial covering the Energy Sector. Michael has been featured in publications such as The Street, Bloomberg, US Money News, and hosts various cannabis events across North America.


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