Invest in MJ Blog

Two more licensed medical marijuana producers have voluntarily recalled hundreds of grams of the drug after traces of a controversial pesticide banned in Canada were detected in their supply, raising questions about Ottawa’s oversight of an industry expected to explode with the upcoming legalization of cannabis.

Last week, Organigram, a publicly traded grower based in Moncton, expanded a Dec. 28 recall of a small amount of product to include almost all of its cannabis buds and oils produced in 2016.

On Monday, Aurora Cannabis Enterprises Inc., a publicly traded firm based in Alberta, announced it had recalled seven lots of cannabis it had bought from Organigram and sold to its clients – through the mail-order system overseen by Health Canada – from August to October of last year.

On Monday cannabidiol (CBD) producers and distributors in the UK started to receive letters from the Medicines and Healthcare Products Regulatory Agency (MHRA) demanding that they cease to sell, supply, promote, advertise or process orders for CBD products within 28 days. The letters stated that CBD now satisfies the definition of a medicinal product. The revised definition will leave UK patients with no legal access to CBD.

Officials with the MHRA are due to release a statement tomorrow, Oct. 7, to clarify the position. A spokesperson from the agency released the following statement:

We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ licence before they can be legally sold or supplied in the UK. Products will have to meet safety, quality and effectiveness standards to protect public health.

We have written to UK CBD stockists and manufacturers to inform them of our view. These products will require a marketing authorisation to be granted before they can be legally sold, supplied or anywhere advertised in the UK.

Individuals who use CBD for treatment should take questions to a health care professional, the MHRA said, adding, “We can provide regulatory guidance to any company who may wish to apply for a licence.”

Peter Carroll of the End our Pain campaign, a UK medical cannabis patient advocacy group, said that “we agree that there is a need for more control in the CBD market to protect people from unscrupulous suppliers and to make sure that people understand what they are taking.” But, he added, “we fear that today’s sudden move will cause huge distress to people who rely on these products.  It will drive many people to look for CBD on the black market. It is a sledgehammer to crack a nut.”

This decision further complicates the status of medical cannabis in the UK. The definition of CBD, one of the main active ingredients in cannabis, as a medicinal product is in stark contrast with The Misuse of Drugs Regulations 2001 scheduling of cannabis as having “no medicinal value”. This adds another exception to the 2001 Regulations, the other being Sativex, a cannabis-extract which is available in very limited circumstances for some MS suffers.

CBD has been soaring in popularity recently as many people purchase it in a variety of forms either as an aid to relaxation, in an attempt to quit nicotine, or for a number of serious ailments and medical conditions. CBD has been linked to a number of potential medical applications with strong anecdotal evidence of its efficacy in treating epilepsy, anxiety, depression, and multiple sclerosis, among many other conditions.

GW Pharmaceuticals, producer of Sativex, released the results of its latest phase III clinical trial for Epidiolex, a liquid formulation of CBD, on September 26. The company hopes to achieve approval in Europe, but the product is still at trial stage and not available for patients. The product is in development for the treatment of a number of conditions, specifically rare pediatric epilepsy disorders including Dravet Syndrome and Lennox-Gastaut Syndrome.

It is unclear how long, or costly, the license application will be for current CBD vendors and whether any will in fact be successful. Medicinal products must meet certain standards before being granted a marketing authorization. Interestingly, the MHRA states that “proof of efficacy generally relies heavily on clinical trial evidence, and no products must be marketed pending any license application.” To date there have been some exciting but very limited trials around CBD but there is a lack of full clinical trial evidence. The process could take years, and it is unclear whether the results of the Epidiolex trials will be relevant to other CBD products or limited to a unique GW Pharmaceutical formulation.

There have been many concerns over the unregulated CBD market. Until now, companies were able to sell CBD products so long as they did not make any medical claims about the product. There were stories of companies breaching this condition as well as providing products of dubious origin and quality. Regulation and standards of some sort will likely be welcomed by the industry but there are serious concerns over the cost, time and process involved in making license applications.

The short deadline of 28 days will come as a worrying shock for the thousands using CBD. Many will question whether this very short deadline is in the best interests of patients. For the time being we simply don’t know how long it will be before patients relying on CBD will be able to legally access their medicine in the UK.

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Democratic presidential nominee Hillary Clinton spoke out against legalizing marijuana in a paid speech, hacked emails from her campaign show.

During an on-stage Q & A session with Xerox’s chairman and CEO in March 2014, Clinton used Wall Street terminology to express her opposition to ending cannabis prohibition “in all senses of the word”:

URSULA BURNS: So long means thumbs up, short means thumbs down; or long means I support, short means I don’t. I’m going to start with — I’m going to give you about ten long-shorts.

SECRETARY CLINTON: Even if you could make money on a short, you can’t answer short.

URSULA BURNS: You can answer short, but you got to be careful about letting anybody else know that. They will bet against you. So legalization of pot?

SECRETARY CLINTON: Short in all senses of the word.

The excerpt comes from an internal Clinton campaign memo highlighting potentially problematic passages from her paid speeches to Goldman Sachs, General Electric, Deutsche Bank and other major corporations.

Other excerpts from the 80-page document, published by Wikileaks after a hack on Clinton campaign chairman John Podesta’s email account, show the former U.S. secretary of state admitting she is “far removed” from the struggles of the middle class, arguing that politicians need to have separate positions on issues in public and in private and supporting “open trade and open borders.”

Over the course of the past year, the Clinton campaign forcefully refused calls to release the speech transcripts from her Democratic primary opponent, U.S. Sen. Bernie Sanders, who supports legalization and has introduced legislation to end federal marijuana prohibition.

That the campaign flagged the candidate’s opposition to legalization as a potential problem demonstrates a growing understanding by political operatives that marijuana law reform is now a mainstream issue, one which is supported by a majority of Americans and a supermajority of Democratic primary voters.

While Clinton has made no secret in public appearances that she isn’t ready to endorse full legalization, she has usually framed her position as taking a wait-and-see approach, wanting to give laws like those in Colorado and other states a chance to work before she makes up her mind about ending prohibition.

The leaked Xerox excerpt, in contrast, positions her as strongly opposed to legalization.

But the remarks were made two-and-a-half years ago, just two months after legal marijuana sales began in Colorado, so it is possible that Clinton’s personal view of legalization has legitimately softened in the interim.

During the course of her presidential campaign, Clinton has highlighted support for letting states set their own cannabis policies without federal interference and has pledged to reschedule marijuana under the Controlled Substances Act if elected.

But advocates have pushed the candidate to go even further by offering a personal endorsement for the policy of legalization, arguing that doing so could help Clinton win back support from wayward millennial voters who are supporting Libertarian Party candidate Gary Johnson or Jill Stein of the Green Party, both of whom have made support for ending cannabis prohibition centerpieces of their campaigns.

The newly-leaked documents showing Clinton’s strong opposition to legalization in a private appearance, combined with comments from the candidate’s daughter Chelsea last month implying that marijuana use can lead to death, could present an added sense of urgency for Clinton to evolve on the question of ending prohibition prior to Election Day.

Original Article BY TOM ANGELL ON OCTOBER 10TH, 2016 AT 11:18 AM | UPDATED: OCTOBER 10TH, 2016 AT 11:28 AM LAW & POLITICS, PEOPLE,

Medical marijuana is legal in 23 states including New Jersey, but the ubiquitous social media giant Facebook apparently doesn't "like" it. Home pages run by three Garden State dispensaries and at least handful of others across the country have been deleted. 

The surprise move stunned dispensary owners and angered patients, who said Wednesday they rely on the up-to-the-minute information these sites provide about the latest strains that help alleviate debilitating symptoms.

"It seems high-handed to simply shut down important resources for sick patients without even saying why or giving organizations a way to ask for reconsideration," said Peter Rosenfeld, one of the 5,668 registered patients in the state program. "What better use of a social media than having sites where parents of sick children can ask questions about medication and treatments?"

In an email, the Facebook media relations office declined to answer questions, and referred NJ Advance Media to the community standards section on its homepage.

Officials from Breakwater Wellness and Treatment Center in Cranbury and Compassionate Sciences Alternative Treatment Center in Bellmawr said their home pages were shut down Tuesday. When they tried to use their home page, they found an electronic message that said: "We remove any promotion or encouragement of drug use."

"Your page is currently not visible on Facebook. It looks like content on your page does not follow the Facebook Community Terms and Standards."

"The site does not allow ads that promote the sale or use of . . .illegal, prescription, or recreational drugs," according to the advertising policies' page.

Marijuana possession and production violates federal law, although the Obama administration has publicly announced that it would not devote law enforcement resources to investigating lawful use permitted by state statutes.

Breakwater founder Alex Zaleski called Facebook's actions "a great disservice to our patients who rely on us to keep them updated on what is going on. We are looking into the matter and hope to resolve it in the patients' favor as soon as possible."

Although each of the five dispensaries in the state have their own web page, the Facebook presence is important because the state rules prohibit advertising, Compassionate Sciences General Manager Michael Nelson said.

Facebook is "incredibly important because the state limits what we can do on our website," Nelson said. "It allows us to post strain names which allows people to do research. It allows the communication between the patients about what is working."

The Facebook presence for Garden State Dispensary in Woodbridge is also missing, but a dispensary representative could not immediately be reached. But the pages for Greenleaf Compassion Center in Montclair and Compassionate Care Foundation in Egg Harbor Township remained active as of 3 p.m.

News about Facebook's actions made for passionate fodder on the Facebook home page of the Friends of the Medical Marijuana Coalition of New Jersey Wednesday.

"It makes me question whether any of us should continue to use FaceBook. Maybe it is time for people to migrate to new ways of communicating," Rosenfeld said.

It's unclear how many legal medical marijuana and recreational marijuana operations have been affected. Dispensaries in Maine and Washington have taken to Facebook's community forum in the last three months to complain about the unilateral decision to disconnect their social media presence.

"I am a dentist and I also own a legal marijuana business in Washington State. I run tasteful ads. Right now, my page has been deleted by facebook, but my competitor...is advertising tons of marijuana on facebook, with no problems from you. Why are you focusing on me, but no one else?"

"I expect an answer soon or at least let me know the next step or should I just start legal action? I feel you are not dealing with this in a fair manner."

The original article written by Susan K. Livio at NJ Advance Media for NJ.com, can be found at :
http://www.nj.com/healthfit/index.ssf/2016/02/facebook_cancels_pages_for_medical_marijuana_dispe.html

Contributed to The Globe and Mail - Published Monday, Nov. 02, 2015 5:00AM EST
Anthony Wile is chief editor of the economic and investment newsletter The Daily Bell and chief investment strategist of High Alert Investment Management.

The election of Justin Trudeau’s Liberals has had an immediate impact on the investment marketplace, with a rush to invest in the handful of publicly traded Canadian medical marijuana startups – all on the promise of legalization of recreational marijuana use.

However, as with any burgeoning new industry, including the Canadian cannabis industry as it “whitens” from its previous black-market status, investors considering directing their capital there may want to take a temporary respite from hitting the go button.

Investors who make assumptions today about what may be profitable tomorrow will likely find their wallets considerably lightened by a changing set of regulatory circumstances.

While a legalized cannabis industry means a substantial increase in potential profitability for the industry leaders already invested in the marketplace, for all investors the key questions are: What will that new landscape look like? How will the industry be regulated, structured and taxed? And, most importantly for the new or individual investor – how best to navigate the marketplace?

A historic deal between the Suquamish Tribe and the State of Washington was recently signed and entered into.  It allows a Native American Tribe to cultivate, process, and sell marijuana within a state’s highly regulated marijuana system.  While the Tribe’s own marijuana regulations have not been disclosed to the public, this does set a precedence and we expect more Native American tribes will follow suite in various States around the US and in other countries like Canada.

The Washington State Liquor and Cannabis Board negotiated the compact with the Suquamish Tribe on behalf of the state. In the compact, the state gives its own interpretation of the Wilkinson statement, writing that “[t]hat memo effectively treats tribal governments the same as state governments in the decision to legalize marijuana.”

Hilary Bricken’s provides her analysis, “The Suquamish Marijuana Compact: First in the State, First in the Nation”:  http://www.cannalawblog.com/the-suquamish-marijuana-compact-first-in-the-state-first-in-the-nation/

Boulder, Colorado-based Tradiv is raising a $1 million round as it gears up to launch its B2B marketplace for cannabis cultivators, marijuana infused product companies, and dispensaries.

That’s right: The B2B pot ecosystem is unfolding right before our eyes.

Backed by Cannabis accelerator CanopyBoulder and accelerator partner Micah Tapman, Tradiv revealed the raise in a public filing with the U.S. Securities and Exchange Commission. The weed startup has so far raised $650,000, according to the filing — at least $20,000 of which likely came from CanopyBoulder, in exchange for a whopping 9.5 percent equity stake. The filing also lists Emily Paxhia, partner of Cannabis-only fund Poseidon Asset Management; and former Microsoft Surface manager, Nick Hofmeister.

See Original Blog Post

August 5, 2015 

Pennsylvania drugmaker Zynerba Pharmaceuticals ($ZYNE) is making its way to Wall Street with some cannabis-derived treatments for central nervous system disorders, raising $42 million in an IPO.

The company priced 3 million shares at $14 each, the middle of its range, and set aside another 450,000 shares for its underwriters to line up for as much as $51.8 million in total.

With the proceeds, Zynerba will press forward with a pair of early-stage transdermal patches that mete out cannabinoid chemicals to treat a host of CNS ailments. ZYN002, slated to enter clinical trials in the second half, has shown promise in refractory epilepsy, Fragile X syndrome and osteoarthritis pain, the company said. And ZYN001, in line for Phase I next year, targets fibromyalgia and peripheral neuropathic pain.

The promise of cannabis-derived pharmaceuticals has drawn a slew of companies to the field over the past few years, including GW Pharmaceuticals ($GWPH) and Insys Therapeutics ($INSY). But unlike its further-along competitors, Zynerba's treatments are synthetically manufactured and don't require growing and maintaining cannabis plants, which the company bills as a practical and financial advantage. Furthermore, Zynerba's transdermal therapies get their active ingredients straight into the circulatory system, avoiding the bioavailability issues that can plague oral treatments that must first navigate the stomach and liver.

Zynerba is led by CEO Armando Anido, appointed in 2014 after stints at the helm of Auxilium Pharmaceuticals, acquired by Endo Pharmaceutical ($ENDP) for about $2.6 billion, and NuPathe, which went to Teva ($TEVA) for $144 million last year.

Meanwhile, biotech's ongoing IPO boom has continued unabated into the second half of 2015, marked by a record debut for Patrick Soon-Shiong's NantKwest ($NK). And the queue of drug developers angling to go public remains full, as Zynerba joins a group including gene therapy outfit Gensight Biologics and food allergy biotech Aimmune Therapeutics.

The original post can be seen here.

Economy of Scale - The cost advantage that arises with increased output of a product. Economies of scale arise because of the inverse relationship between the quantity produced and per-unit fixed costs; i.e. the greater the quantity of a good produced, the lower the per-unit fixed cost because these costs are shared over a larger number of goods. Economies of scale may also reduce variable costs per unit because of operational efficiencies and synergies. Economies of scale can be classified into two main types: Internal – arising from within the company; and External – arising from extraneous factors such as industry size. – “Investopedia”

I am constantly asked “how can I expand my cannabis business across state borders?”  I am then forced to explain how the U.S. system of federalism works.  Even though medical and/or recreational use of cannabis may be legal in your state, it is not legal on a federal level.  Why?  This boils down to the same issue concerning banking for the cannabis industry – the Schedule I Classification of cannabis makes its possession, use, cultivation and/or sale a federally illegal activity.  Then logically following, from a federal perspective, the proceeds of activities involving Schedule I “drugs” are the proceeds of illegal activities. 

Constitutional law then forces us to examine two important issues – (i) Preemption and (ii) Interstate Commerce.  The “Supremacy Clause” states that state laws which conflict or contradict federal law, are null and void.  Federal law is therefore the “law of the land”.  So in essence, all state legalization of cannabis, in any category, will not be “legally” recognized by the federal government with respect to law enforcement.  These real battles are being fought every day in states that have legalized cannabis use.  For the moment, the federal government seems to content to allow the great cannabis experimentation to continue, while occasionally issuing “safe-harbor” guidance that is quickly disregarded.

These days it’s harder than ever to break through, especially in an industry whose bandwagon is quickly filling up like the SF cable car. There is so much noise, everyone is screaming and trying to get their message across, staking their claim in the green rush. It’s great in the sense that without gatekeepers more people are able to express their ideas, but the downside is that it’s harder than ever to actually be heard. I, personally, like when the best ideas win.

So, how do you find your breakthrough idea? Many people know generally where they want to go, but it takes more than that. There are five major ways to get to your “idea destination”. You don’t even have to do all five. Pick one and execute it well. That’s enough to make your name in the cannabis industry. 

Start with a niche strategy then expand strategically outward

You can’t just say I’m going to be the expert in something. In that category, you will compete with the entire world. You have to narrow it down. The secret to that however, is that you don’t want to be pigeonholed doing that. You need to move into new territory from there. It’s all about circling the area around a niche. A good niche is one that you can become the master of, because the big players in the industry only talk about it periodically. Where do you get the seed for finding a niche? Well, solving your own problem is one way. If you are in a situation, others are too. Also, draw from your personal experiences. Notice needs and find a solution.