Here we are.

It’s taken years of trials and experiments, but this week, the U.S. Food and Drug Administration (FDA) made history by approving the first cannabis plant–derived drug pharmaceutical.

And that makes the drug’s developer and owner, as well as our longtime Roadmap to Marijuana Millions cannabis biotech play – the United Kingdom’s GW Pharmaceuticals Plc. (Nasdaq: GWPH) – a pioneer in marijuana-based medical treatments.

What a week to be early investors in weed…

When taken in the light of Canada’s full legalization of marijuana last week, the 16 U.S. states deciding on legalization measures this year, and the new mega-player(s) about to get into legal marijuana, it’s going to add up to windfall profits potential for the best-positioned companies.

This Has Been a Long, Immensely Profitable Story

In fact, I first mentioned this unique cannabis-focused biotech firm back in the spring of 2014 for Money Morning, because it was singularly focused on the huge profit potential in developing several cannabinoid therapeutic drugs.

This includes its now FDA-approved treatment, Epidiolex.

Epidiolex was created to provide a better solution for two difficult-to-treat forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that mainly affect young children. Most patients afflicted with either currently have high rates of mortality and require multiple forms of seizure medications to treat their symptoms.

This twice-daily oral solution is a pharmaceutical formulation of purified cannabidiol (CBD), but it doesn’t give the high associated with tetrahydrocannabinol (THC) in marijuana.

This drug could be a godsend to patients in the United States who are two or older… a standout feature I spotted early on in this cannabinoid pharmacology pioneer.

Aside from launching in the U.S. market, GW Pharma is hoping to provide its epilepsy treatment in Europe, where it’s under review by the European Medicines Agency.

We’ll definitely want to hold this company in anticipation of what could happen overseas.

That’s because, since I first recommended GW, the stock has zoomed to hit peak gains of more than 1,100% – 75% of that since I “officially” added it to my Nova-X Report’s Roadmap to Marijuana Millions model portfolio. In fact, of the six cannabis-pharma picks I’ve highlighted there for my paid-up subscribers, GW Pharma always held “first-mover” advantage, having been in cannabis research since the late 1990s, long before anyone else in the sector.

The company is so far out in front, the government is forced to play catch up, even after FDA approval.

You see, as GW Pharma said, the fact that the U.S. Drug Enforcement Agency (DEA) will need up to 90 days to reschedule Epidiolex from the strictly prohibitive federal Schedule I, after which the product will become available, may have caught some investors by surprise.

But make no mistake, this is big, big news for GW Pharma – and for the broader cannabis-based pharma niche in general, as the regulatory door has now swung wide open.

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 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 other companies in this lucrative market niche, many of which sport stock prices that look more like GW did back in 2013 – far less expensive.

— Michael A. Robinson

Source: Money Morning