GW Pharmaceutical Gets Closer To Forcing Cannabis On FDA

Cannabulletin: Your source for Aggregated Cannabis News View this email in your browser (http://us12.campaign-archive2.com/?u=6f95bb3d20482a8e9e013f802&id=ed8a9970f0&e=d756ab8267) 10/04/2016

** Welcome to Cannabulletin

Cannabis News that Informs, Intrigues & Captivates.

** Alaska’s First Legal Cannabis Harvest Just Began. It’s Already Stalled. (https://www.leafly.com/news/politics/state-leaf-alaskas-first-legal-cannabis-harvest-just-began-already-stalled/)

** Alaska

Alaska’s first commercial cannabis harvests are underway (http://www.adn.com/slideshow/alaska-marijuana/2016/09/25/alaskas-first-commercial-cannabis-harvest-begins/) . The first official legal crop comes from Greatland Ganja, a small cultivator on the Kenai Peninsula. Greatland has harvested about 75 pounds of cannabis so far, of an expected total of about 100 pounds consisting of 10 different strains. Unfortunately, however, the first harvest may not have anywhere to go. Distribution and sales are stalled until state-licensed testing laboratories are up and running. At the moment two labs are nearing completion in Anchorage: CannTest hopes to open by mid-October and AK Green Labs aims to be online by early November.

** Wholesale cannabis price drops 40 percent (http://www.boulderweekly.com/features/wholesale-cannabis-price-drops-40-percent/)

According to Tradiv, a cannabis trading platform based in Boulder, wholesale cannabis prices have fallen from approximately $2,500 per pound in October of 2015 to around $1,500 per pound in August of this year.

In the beginning of Colorado’s legal market, companies didn’t know what to expect in terms of demand or supply but one things was for sure, it was growing quickly. The price point was high, in part a reflection of the novelty of legal cannabis and pent up demand. Now almost three years old, the market is beginning to stabilize, but consumers should expect a few more tremors as the foundation of the market shifts and settles into place.

“The problem was that that growth was not projectable nor was it understood,” says Mike Bologna of Green Lion Partners, a strategic development firm for the cannabis industry. “Nearly three years later, the state is still experiencing growth — the last three months are the highest retail sales on record to date — but the rate of growth is beginning to slow, but as it does it also becomes more predictable.”

Some of this stabilization is due to the regulatory frameworks designed to slow and control growth, like Denver’s moratorium on new licenses or stringent limitations on new businesses in Boulder. [Read More (http://www.boulderweekly.com/features/wholesale-cannabis-price-drops-40-percent/) ]

** How to Incorporate Cannabis into Traditional Jewish Food for Rosh Hashanah (https://www.merryjane.com/health/cannabis-jewish-food-rosh-hashanah)

The evening of Oct. 2 marks the start of Rosh Hashanah, the Jewish New Year. Like most Jewish holidays, it is celebrated with a festive meal full of traditional, delicious food. While cannabis is not a customary ingredient used in most Rosh Hashanah meals, it is something that could bring some new flavor and feeling (https://www.merryjane.com/health/how-to-cook-with-marijuana) to your holiday table.

To help you prepare the highest High Holiday meal ever, MERRY JANE spoke with cannabis chef JeffThe420Chef (http://www.jeffthe420chef.com/) , who’s been hosting “Pot Shabbats”—cannabis-centered Sabbath meals—for a while now. He even included many traditional Jewish recipes with cannabis twists in his recently released cookbook, The 420 Gourmet: The Elevated Art of Cannabis Cuisine (https://www.amazon.com/420-Gourmet-Elevated-Cannabis-Cuisine/dp/0062445057) .

“Cannabis use dates back to when we were in Egypt,” says Jeff of the relationship between Jewish people and the plant. “Ancient Pharaohs were buried with cannabis in the pyramids! It’s also kosher!”

For those of you planning on serving a highly special High Holiday meal this Rosh Hashanah, Jeff offers these tips:

** Use a simple replacement.

One of the easiest ways to incorporate the ancient herb into your holiday meal is with apples and honey. Jewish people traditionally dip slices of apples into honey to encourage a sweet new year. Buy some cannabis-infused honey and you’ll take this tradition to the next level.

** Focus on effect.

As far as cooking and what type of cannabis to use, Jeff is less concerned with strain than with effect. “Make sure to find a good, uplifting strain (https://www.merryjane.com/goods) ,” he says. It’s a celebration, after all. You don’t want to bring the party crashing down.

** Make it all about the food.

If you’re cooking with cannabis, your guests shouldn’t also be smoking or drinking in abundance. You don’t want people to “cross-fade.”

** Keep it cool.

If you’re cooking or baking, never go above 340 degrees (https://www.merryjane.com/culture/cannabis-decarboxylation-methods) . Anything above that will start to burn off both the THC and CBD. Brisket is perfect for this because the best way to cook it is low and slow.

** Dose properly and inform everyone.

Whenever you cook with cannabis (https://www.merryjane.com/health/5-things-to-avoid-when-cooking-with-marijuana) , you should make sure to not only let guests know which dishes have cannabis in them, but also how much is in each serving. The standard edibles dose (https://www.merryjane.com/culture/cannabis-decarboxylation-methods) is 10mg. You want to prepare your recipes so you know approximately how many milligrams of cannabis there are per serving. Jeff details these amounts next to each recipe in his cookbook (https://www.amazon.com/420-Gourmet-Elevated-Cannabis-Cuisine/dp/0062445057) , and he also has an incredibly helpful cannabis calculator (http://www.jeffthe420chef.com/calculator) on his website that you can use.

** Always create a virgin option.

While it might be tempting to have an entire meal laden with cannabis, reality dictates that too much of any edible is not a good thing. So, if you’re making Jeff's“Potzo Ball Soup” (http://www.jeffthe420chef.com/single-post/571a68a30cf2dd6f7fc9256e) recipe, make sure to also have a batch of non-cannabis-infused matzah balls ready to go. This allows guests to medicate and enjoy the meal at their own pace.

** GW Pharmaceutical Gets Closer To Forcing FDA On Cannabis (http://www.forbes.com/sites/debraborchardt/2016/09/28/gw-pharmaceutical-gets-closer-to-forcing-fda-on-cannabis/#1273af5422d9)

British biotech company GW Pharmaceuticals (http://www.gwpharm.com/) announced positive results on its latest Phase 3 clinical trial for its drug Epidiolex. The drug is cannabidiol-based and is used to treat children with Lennox-Gastaut syndrome, a rare form of childhood epilepsy.

The results from the test were very positive. Patients taking 20mg of Epidiolex saw their seizures on average drop 42% compared to a drop of 17% in patients taking a placebo. Patients taking 10mg of Epidiolex experienced a 37% drop in seizures versus the 17% drop in the placebo group.

The next step for GW Pharmaceuticals is to seek approval from the U.S. Food and Drug Administration or FDA for approval. The company said it expects to submit a New Drug Application with the FDA in the first half of 2017. If approved, it would be the first plant-derived cannabinoid drug in the U.S. to be approved. After the FDA approves a new drug application, the Drug Enforcement Administration (DEA) legally must reschedule within 90 days (per the Improving Regulatory Transparency for New Medical Therapies Act (https://urldefense.proofpoint.com/v2/url?u=https-3A_www.congress.gov114plawspubl89PLAW-2D114publ89.pdf&d=CwMGaQ&c=4ZIZThykDLcoWk-GVjSLm9hvvvzvGv0FLoWSRuCSs5Q&r=aCFBvqpJ0fSB0thePY28bErwpOz9ri77RFHWE-R20uTKjj4itbcib9xRpnKuNhj9&m=TXZjeTbCpw-Fg8HWBrzCPOaQ7YdkpX6u09rJUgY0VXU&s=K7v-3myoAw3jNE7cfhgONTXbENNti2eqxYcag2_Lsg&e=) ). So, Epidiolex would be rescheduled by DEA within 90 days, but overall marijuana would not be rescheduled.

GW Pharmaceuticals is quick to point out that Epidiolex is not marijuana. Epidiolex is an oral pharmaceutical formulation of cannabidiol, one of many cannabinoids found in the cannabis sativa plant. CBD is a non-psychoactive component of the cannabis plant.GW Pharmaceuticals does not want its product to be confused with medical marijuana.

Having said that, this further complicates the rescheduling argument. How could the DEA declare Epidiolex, cannabinoid drug a medicine, but then still insist marijuana has no medicinal benefits? Of course, they do that now because the U.S. government has medical patents on marijuana and still declare it has no medicinal qualities.

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