The Illusion of a Free Market Economy. "DEA Grants Pharmaceutical Company Monopoly on Medical CBD"

GW Pharmaceuticals sounds like it is in a prime position to be acquired by the new mega corp of Bayer/Monsanto as they are rumored to be bullish on cornering the Cannabis ( & Hemp) market.

"The decision concerned a recently FDA-approved pharmaceutical version of CBD, produced by GW Pharmaceuticals. Due to the federal government’s continued prohibition of cannabis, Epidiolex was prohibited from going to market unless the DEA rescheduled CBD. That’s what the agency did, leading some to believe that “since this FDA-approved medication is pure cannabidiol (CBD) that all CBD products fall into the same category,” Forbes noted."

"But that is not the case. The DEA decision applies only to “FDA-approved” drugs, meaning they have just granted GW Pharmaceuticals a monopoly on plant-derived CBD (hemp-derived CBD is no longer restricted). The DEA said as much in a statement to NBC affiliate WTHR:

“What this does not do is legalize or change the status of CBD oil products,” DEA spokesperson Rusty Payne said. “As of right now, any other CBD product other than Epidiolex remains a Schedule I controlled substance, so it’s still illegal under federal law.”

source: https://www.blacklistednews.com/article/68788/dea-grants-pharmaceut...

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Comment by Raz Putin on October 15, 2018 at 11:12pm

From GW Pharmaceuticals official site:

In just one year following its inception, GW commenced its first clinical trials evaluating different cannabinoid formulations as potential therapeutics with an initial focus on the development of an oral mucosal spray with two principal cannabinoid components, cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC).

https://www.gwpharm.com/about-us/history-approach

Working with leading cannabinoid scientists around the world, GW has continued to explore the potential of a range of novel cannabinoid molecules in a number of distinct therapeutic areas including epilepsy, glioma, and schizophrenia.

GW’s lead product candidate, is a liquid formulation of highly purified CBD being investigated for severe earlyonset, drug-resistant epilepsy syndromes. This product is the result of extensive pre-clinical research of CBD in epilepsy which dates back to 2007. In 2013, GW commenced an orphan clinical program in paediatric epilepsy with initial focus on two rare and particularly difficult to treat forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome (LGS), both of which have been granted orphan drug designation by the U.S. FDA.

GW submitted a New Drug Application with the FDA , which was approved by the FDA on June 25th, 2018 for the treatment of seizures associated with LGS or Dravet syndrome. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in the first quarter of 2019. To date, GW has received Orphan Drug Designation from the FDA for Dravet syndrome, LGS and TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for the treatment of LGS, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders."

 

 

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