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U.S. FDA Approves First Marijuana-based Pharmaceutical

0 | By Michael A. Robinson

Today, the U.S. Food and Drug Administration (FDA) smashed the glass ceiling when it comes to cannabis.

The agency has approved the first cannabis-based drug in its history…

It comes in the wake of Canada’s full legalization of marijuana last week, and with 16 U.S. states deciding on legalization measures this year.

The FDA approved the United Kingdom’s GW Pharmaceuticals’ (Nasdaq ADR: GWPH) cannabidiol (CBD) epilepsy drug, Epidiolex. That gives patients two years and older with the rare forms of difficult to treat, childhood onset epilepsy known as Dravet Syndrome and Lennox-Gastaut Syndrome the ability to use the drug.

Epidiolex is an oral solution derived from CBD and contains less than 0.1% THC, the psychoactive ingredient in marijuana that gets people high.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies” said FDA Commissioner Scott Gottlieb.

The news is huge for GW Pharma, and for the broader cannabis-based medicine industry in general, as the regulatory door has now swung wide open.

Now, I recommended GW Pharma to my Nova-X Report readers two years ago, before a significant price run up. And that’s just the beginning. I also picked several other pharma companies with an interest in producing cannabis-based medicine.

And now with GW’s approval, the template has been set for pharmaceutical companies – several of which have been in my model trading portfolio for more than a year.

Don’t just take my word for it. The floodgates are about to open on CBD products, pharm-based treatments and possibly even some non-THC products in the nutraceuticals space, according to what U.S. Drug Enforcement Administration (DEA) public affairs officer Barbara Carreno describes as the “sea change” effect.

That’s a situation where a market pioneer like GW paves the way for others, many of whom with stock prices that are far less expensive to buy.

After that happens, CBD manufacturers would be compelled to register with the DEA, which will in effect end the grey market where companies don’t know if their CBD products are legal or not, according to the Pot Network.

GW Pharm believes the DEA should reschedule Epidiolex from the prohibitive federal Schedule 1 distinction within 90 days, after which the product will become available.

“Today’s approval of Epidiolex is a historic milestone,” said Justin Gover, GW’s Chief Executive Officer. “Patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

Now, I’m going to talk more about which pot stocks are best positioned to profit from this extraordinary development later this week in Nova-X.

Join me there, or stay tuned here as we learn more about this development…

Cheers and good investing.

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