For more than a year now, all eyes have been on Canada. The introduction of Bill C-45, which you might know better as the Cannabis Act, outlined a means to legalize recreational marijuana in our neighbor to the north. Since no developed country has ever legalized adult-use weed before, businesses and investors saw billions upon billions of dollar signs dancing in their heads.
This long-running expectation of legalization is what’s pushed Canada’s growers to expand their production capacity at an incredibly quick pace. For instance, Aurora Cannabis had begun the year with a little over 100,000 kilograms in expected peak annual production. Now, following two monstrous acquisitions (one of which is ongoing), a new partnership, and the announcement of another massive greenhouse project, Aurora Cannabis is staring down 570,000 kilograms in peak annual production, at full capacity.
The story is similar for Canopy Growth Corp., which has tripled its licensed growing capacity to 2.4 million square feet through the first five months of 2018, and has plans to push its licensed grow space to 5.7 million square feet. These two pot juggernauts could produce well over 1 million kilograms of cannabis a year between them.
Forget Canada! This is a much more important vote
Yet, for as intriguing a story as legalization makes in Canada, it may not be as big of a game changer as what…
GW Pharmaceuticals (NASDAQ:GWPH) looks poised to do in the United States.
You see, the U.K.-based cannabinoid-based drug developer has its lead drug, a cannabidiol (CBD)-based oral medicine known as Epidiolex, under review by the Food and Drug Administration (FDA) for the treatment of two rare types of childhood-onset epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. CBD is the nonpsychoactive component of the cannabis plant that’s perhaps best known for its perceived medical benefits.
At no point in history has the FDA ever approved a drug derived from the cannabis plant. Sure, synthetic versions of tetrahydrocannabinol (THC), the psychoactive component of the cannabis plant that gets you “high,” have been given the OK, but never a cannabinoid-based drug derived directly from the cannabis plant.
In numerous pivotal-stage clinical studies, Epidiolex met the mark of statistical significance with regard to reducing seizure frequency relative to baseline and a placebo. In one Dravet syndrome study, Epidiolex produced a three times’ greater reduction in seizure frequency from baseline (39% vs. 13%) relative to the placebo. Meanwhile, a Lancet-published study on Lennox-Gastaut patients found that Epidiolex doubled the median reduction in drop seizures from baseline (44% vs. 22%) relative to the placebo.
In mid-April, the FDA’s advisory panel reviewed Epidiolex’s clinical data and recommended it for approval in a unanimous vote. Though the FDA isn’t bound by the opinion of its advisory panel, it tends to follow its suggestion more often than not.
With no FDA-approved treatments for Dravet syndrome, and few FDA treatments available for Lennox-Gastaut syndrome, Epidiolex has the potential to come roaring out of the gate, if approved on or before its…
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