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The DEA has been taken to court by the cannabis industry after a contentious new statute on the extracts of the plant. Denver’s Hoban Law Group (who is representing the Hemp Industries Association, Centuria Natural Foods and RMH Holdings LLC), filed a judicial review action on Friday against the U.S. Drug Enforcement Administration, pleading the agency overstepped its boundaries when enacting a rule establishing coding for cannabis derivatives such as cannabidiol (CBD) oil. Hoban lawyers allege that the action puts a thriving hemp and marijuana industry at risk and a wide variety of cannabis-based products currently on the market. Bob Hoban said, “We’re talking about jobs and the economy and agricultural (revival).”

Last month the DEA angered many advocates in the marijuana industry with the filing of a final statute notice establishing a Controlled Substances Code Number for “marijuana extract,” and subsequently maintaining cannabis, hemp, and their derivatives as Schedule I substances. DEA agents said the code number would help in the tracking of materials for research and would aid in complying with treaty provisions. However, compliance attorney Hoban expressed worry at the time that the language could result in federal agencies viewing products produced from cannabis as against the law.

Hoban’s petition pursues an analysis of the final rule on the basis that the action was not consistent with the law, including the U.S. Controlled Substances Act and the Agricultural Act of 2014, or the Farm Bill, and effectively amounts to a scheduling action. Hoban said a scheduling action would need congressional approval. According to the lawsuit, “Additionally, the final rule creates this new drug code, indicative of being a controlled substance, for substances which are in fact not controlled pursuant to the (Controlled Substances Act),” Hoban attorneys wrote in the lawsuit. “Specifically, the final rule dictates that the mere presence of ‘cannabinoids,’ which are not controlled substances, is the determinative factor of whether a compound is a ‘marijuana extract. Further, the final rule over broadly defines ‘marihuana extract,’ without reflecting that certain portions and varieties of the genus Cannabis sativa L. are congressionally exempted from the CSA and/or are exempted from being treated as controlled substances altogether pursuant to the relevant laws, as enacted by Congress.”

Hoban said his firm plans to file a petition next week with the DEA, requesting the administration to revoke the definition. Hoban stated, “(The new rule) certainly has caused quite a chill in the marketplace over the last three or four weeks. The number of calls we get on a daily basis, you couldn’t even quantify. That is indicative to me of an environment where people are scared, they’re nervous.” Hoban said he does not expect a spike in enforcement. However, he encouraged producers to maintain strict processes and to conduct an audit of their businesses to make sure that they are in compliance with federal and state regulations. Russ Baer, DEA spokesman, stated he could not comment on a petition that he hasn’t seen yet.

Baer addressed the agency’s positions on CBDs marijuana extracts in an email earlier friday: CBD oil and other extracts derived from marijuana will continue to be Schedule I controlled substances, unless and until they are determined to have a current accepted medical use. We need conclusive scientific evidence to make these determinations and the lack of evidence regarding the efficacy of cannabis is impressive. To handle any controlled substance, an entity or individual must be a DEA registrant to be authorized to conduct research with the particular controlled substance.

Under U.S. law (the CSA), the definition of cannabis includes all parts of the marijuana plant that are the source of cannabinoids. The CSA definition of marijuana also includes “every compound, manufacture, salt, derivative, mixture, or preparation” of such parts of the cannabis plant – and CBD produced from the cannabis plant clearly falls within this category. Thus, CBD, being a derivative of marijuana, is marijuana under U.S. law. Accordingly, because cannabis is a schedule I controlled substance under the CSA (as set forth in 21 U.S.C. § 812(c), Schedule I(c)(10)), CBD is a schedule I controlled substance under the CSA.

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Curtin University’s School of Biomedical Sciences will begin testing marijuana formulations against human pancreatic cell cancer lines grown in the laboratory. The project is in association with Zelda Therapeutics, a Perth based biopharmaceutical company, which will be importing the marijuana from Canada. The study will explore all of the possible benefits of marijuana formulations as standalone therapies and in combination with chemotherapy medications.

Pancreatic cancer is exceedingly aggressive and challenging to identify. According to research, only 6% of patients will survive for five years after being diagnosed. Curtin University’s Professor Marco Falasca stated, “After years of slow progress in the field of pancreatic cancer treatment, we hope to finally open the path to new therapies for pancreatic cancer.”

Zelda stated the plan is to duplicate the success of its cannabinoid formulations on breast cancer. In November, Zelda revealed the conclusions of an experimental trial, alleging its THC-rich medical marijuana formula was as sufficient in decreasing breast cancer tumour growth in mice as the chemotherapy medication Lapatanib. The conclusions still need clinical trial acceptance. “There is a growing body of evidence that whole plant cannabinoid extracts can impede cancer growth and potentially render the tumour more responsive to chemotherapeutic agents,” Zelda stated.

Harry Karellis, Zelda’s executive chairman, hoped the pancreatic research would demonstrate anti-cancer activity. He said, “Professor Falasca has an established reputation in studying pancreatic cancer using cannabinoids in Italy, the United Kingdom and more recently, in Australia. Up until now he has been working with synthetic cannabidiol and generating positive data in vitro and in vivo. Our program will be testing our whole plant extracts in his established cell assays and depending on results can progress into further work in animal models.” We are hoping to open up pathways to new pancreatic cancer treatments.

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Biotech Buzz Could Focus On Cannabis

San Francisco will be a hotbed for biotechnology this week. The annual JPMorgan Healthcare Conference kicks off on Monday the 9th and goes through Thursday the 12th. But this isn’t the only conference and there will surely be thousands of investors in the city to attend all kinds of presentations being made, which are focused on biotechnology & healthcare. Outside of just JPM’s conference, the crowd around Union Square also consists of the Biotech Showcase, which sets up at the Hilton San Francisco Union Square; and the OneMedForum across Post Street from the St. Francis.

Biotech_Showcase

There’s also the StartUp Health Festival on Montgomery Street and other conferences. Considering that thousands of people who aren’t going to invitation-only conferences like JPM, it would stand to reason that attention will be on the industry in full force this week.

Recently Vitality Biopharma (VBIO) announced that it would be presenting at the Biotech Showcase on Wednesday January 11th. The Showcase hosts over 2,800 attendees, over 5,600 one-on-one meetings, and will be expecting to see over 550 investors present.

Biotech Showcase™ is an investor and networking conference working to provide private and public biotech and life sciences companies with an opportunity to present to, and engage with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this week, which is widely viewed as setting the tone for the coming year…so JPMorgan is just the tip of the iceberg during San Fran’s biotech invasion.

“Biotech has historically outperformed the broader market during The J.P. Morgan Healthcare Conference,” biotech analysts at the firm wrote in a note to clients ahead of the event.

And we aren’t the only ones who could be seeing the potential “writing on the wall.” One of the presenters at the conference has even said, “…there’s a growing interest in medical cannabis among traditional health care institutions. This is a growing part of what is becoming mainstream health care.” As we said last week, even though we focus specifically on marijuana stocks, the biotech aspect of VBIO could be something to pay attention to heading into this week, considering the historic impact that the JPM conference (starts today) has had in the past for companies that have a stake in the space.

We said that this week could shed some light on many biotech companies including those involved with cannabis. Now we see that VBIO will be at ground zero, not just as another biotech company that could benefit from the shockwave but management will be in the exact location and presenting to the exact audiences.

Company CEO Robert Brooke will provide a 30-minute overview of Vitality Biopharma’s business during his presentation and will be available to participate in one-on-one meetings with registered attendees.

Event: Biotech Showcase Conference
Date: Wednesday, January 11, 2017
Time: 8:00 a.m. PT
Track: Room 8 (Ballroom Level)
Location: Hilton San Francisco Union Square, San Francisco, CA


 

 

Pursuant to an agreement between MAPH and a non affiliate third party, we were hired for a period of 30 days to publicly disseminate information about (VBIO) including on the Website and other media including Facebook and Twitter. We are being paid $100,000 (CASH) for or were paid “ZERO” shares of unrestricted or restricted common shares. We own zero shares of (VBIO) which we purchased in the open market. We plan to sell “ZERO” shares of (VBIO) that we hold during the time the Website and/or Facebook and Twitter Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of ( VBIO) in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. PLEASE READ OUR FULL PRIVACY POLICY & TERMS OF USE & DISCLAIMER

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According to a New York University press release, a new study by researchers at the New York University School of Medicine has discovered a relation between the number of cannabinoid receptors in the brain and the effects of post-traumatic stress disorder (PTSD). This discovery is paving the way towards a more efficient treatment.

This research is the first to use brain imaging to show that patients suffering from PTSD have lower concentrations of anandamide than the average person. The researchers tested 60 people from three different groups: some who have been diagnosed with PTSD, some who have had a history of trauma but no symptoms, and some with a history of neither.

Scientists administered a safe radioactive tracer which illuminated the participants’ CB1 receptors when exposed to a PET scan. The conclusions show that the patients suffering from PTSD had more CB1 receptors in the areas of their brains that are tied in with anxiety and fear than those without PTSD. It was also discovered that people with the condition have lower levels of anandamide, which leads to an increased number of CB1 receptors.

What this demonstrates is that using cannabis could ease some of the effects of PTSD. It could greatly reduce the anxiety, fear, and stress that many who suffer from the disorder feel on a regular basis. The cannabinoids found in the marijuana are what provide such strong medicinal value for the individuals suffering from PTSD.
Researcher and lead author of the study Alexander Neumeister stated, “There’s not a single pharmacological treatment out there that has been developed specifically for PTSD. That’s a problem. There’s a consensus among clinicians that existing pharmaceutical treatments such as antidepressant simply do not work.” He notes that individuals suffering from PTSD typically find more relief from cannabis than antidepressants.

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The battle between the DEA and the Hemp Industries Association was brought back to life after the change last week. Marijuana advocates believe that since hemp isn’t called out under the Controlled Substance Act, it’s legal. The HIA stated, “Cannabidiol is not listed on the federal schedule of controlled substances.” The DEA believes it is since it comes from the same plant.

Executive Director of the Cannabis Business Alliance, Mark Malone states, “This is a huge step backwards for cannabis prohibition and especially for patients who live in states without established medical cannabis laws.”

Manufacturers of CBD products are battling back. Dr. Titus said, “The ninth circuit court of appeals has conclusively held that hemp products such as those marketed by the company [Medical Marijuana] which are derived from the part of the cannabis plant, which is exempt from the controlled substances act is legal for import from Europe.” Dr. Titus believes the products are legal.

Courts ruled that hemp was not a schedule one drug and that the DEA had no right to control it. It also said that hemp was legal to import and sell in the United States. The DEA said it came up with the new internal drug code for extracts of cannabis as a more accurate way to track scientific research on it. Baer stated, “Creating an internal record keeping system allows us to distinguish the extracts from other parts of the cannabis plant and ultimately makes our work more efficient.”

The CBD producers believe the DEA is overstepping the line. New laws cannot be created by the DEA, they can only crack down on laws that already exist created by Congress. Consequently, by making an administrative change they can then include a product that hadn’t been incorporated before.

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1. T.V. Show With Cannabis Theme

Over ten years ago Showtime released Weeds, a series centered on a suburban mother that sold marijuana as her full-time career. Even with its risque topic, it was considered revolutionary at the time. HBO has High Maintenance out currently. Adam Scott from Parks and Recreation was given the greenlight from NBC to create a show called Buds about a dispensary in Denver, however there is no release date for the comedy.

2. L.A. Will Become Cannabis Capital

Chief Executive Officer of marijuana investment firm MedMen Capital, Adan Bierman, believes that Los Angeles will steal the spotlight from Denver, Colorado. Bierman said that by some estimates, Los Angeles’s medical cannabis market alone is already close to a billion dollars, easily outweighing Colorado’s market.

3. Growth Of Specialty Cannabis

Chief Marketing Officer of vaporizer distributor Greenlane, Sasha Kadey, said he predicts that as market supplies grow, prices will fall, becoming commodities in the eyes of the consumers. “This is leading to premiumization,” he stated. “Much like the alcohol industry experienced during its maturation, with producers now seeking to differentiate with premium packaging, brand building, so called “seed to sale” storytelling, and other value adds.” Some farmers will stress their organic features while others push celebrity endorsements. 2017 will be the year of the specialty classifications of marijuana.

4. Interest Increases For CBD oil

It is predicted that interest in cannabinoids (CBD) will increase, even with the DEA and the Hemp Industries Association fighting over the legality of marijuana extracts. Chief executive officer of biotech company Kalytera , Seth Yakatan said, “With AG Sessions and the DEA’s clarification that plant derived CBD isn’t legal federally, there will likely be interest in synthetic forms of CBD, which is what Kalytera has been testing the efficacy of for a few years.”

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An Idaho businessman named Kurt Wilson is worried that the government is aiming to prevent him from selling CBD oil, one of the most popular health products in his store. CBD oil is extracted from the same marijuana plant as THC, but it does not get people high. Wilson’s customers say they have seen great results while using the oil. “There’s over 6,000 years of recorded history of this oil being used, it’s a plant,” Wilson stated. Marijuana is still illegal in Idaho.

Wilson’s business is named Survival Enterprises. His clients are people who want to live an independent style of life. One of the products in his store is CBD oil (Cannabidiol). “This stuff helps them not to be nauseous after chemotherapy, and they don’t have to get goofy by smoking dope or anything like that,” Wilson stated.

Most CBD oils contain less than 1% of THC. Wilson said because of that 1% it is illegal to sell. Wilson stated, “I can give you a gallon of it to drink, and it’s just going to mellow you out a little bit and that’s it, so there’s no drug involved there in any way, shape, or form.” He sells between 30 and 40 bottles a month but it is technically considered a controlled substance by federal standards.

Wilson said his clients do not want to get their medicine from big pharmaceutical companies. They prefer a more natural approach with CBD oil. “What’s occurring here is that, again, we don’t have government, we have corporate representatives. And the corporations have told government we can’t really have competition,” Wilson stated.

Cannabidiol is in a bit of a gray area In Idaho. Wilson said Governor Butch Otter vetoed a bill in 2015 that would have allowed parents to treat their epileptic children with CBD. However, Otter issues an order to research the effectiveness of the oil. Even though it is still illegal, Wilson said it is just the byproduct of a plant.

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The cannabis industry made significant strides during 2016 and we think this is just the beginning…

Although 2016 was a banner year for the cannabis industry, we expect 2017 to be even more significant. As we approach the end of 2016, we want to take the opportunity to highlight the most important themes, the top investments for 2017 and the top 10 stocks flying under the radar.

Today we released Technical420’s Top 10 Cannabis Developments of 2016 and this is the first chapter of a three-part series being released this week.

Top 10 Cannabis Industry Developments of 2016

1. State-wide elections proved to be major success with the approval of recreational cannabis in California, Massachusetts, Maine and Nevada, and the adoption of medical cannabis laws in Arkansas, Florida and North Dakota.

2. GW Pharmaceuticals (GWPH) proves that cannabis has medical benefits by delivering positive FDA Stage III clinical trial data on its Epidiolex cannabinoid product.

3. A Canadian federal task force issued recommendations for the implementation of a regulated recreational cannabis market. The task force recommended using the existing system for medical cannabis to regulate recreational cannabis. They also suggested a minimum age of 18, limitations on packaging, increased caution with edibles and the use of taxes to fund administration, education, research and enforcement. The task force recommended using the same tax system for both medical and recreational cannabis and placing heavier taxes on high potency products to discourage their use by the general public.

4. A cannabis legalization revolution is not just taking place in the United States. We are seeing cannabis reform taking place all around the world. Last year, Puerto Rico Governor Alejandro Garcia Padilla signed an executive order to legalize medical cannabis. In 2014, Uruguay legalized both medical and recreational marijuana. This is a trend that has shown no signs of slowing down as countries including Australia, Germany, Jamaica, Israel, Netherlands Portugal and Uruguay continue to advance the legal cannabis industry.

5. Wall Street significantly increased its focus on the cannabis industry. This development was highlighted by Goldman Sachs initiating coverage on GW Pharmaceuticals (GWPH), boutique-investment bank Cowen and Company initiating coverage on OTC-traded Kush Bottles (KSHB), and Morgan Stanley assisting with potential cannabis M&A activity.

6. Canopy Growth Corp (CGC.TO) (TWMJF) became the first licensed Canadian medical cannabis producer to have a $1+ billion market capitalization. Canopy continues to be a global cannabis leader as it continues to expand its presence internationally and make strategic acquisitions (recently announced the acquisition of Mettrum Health)

7. The Gallup poll showed record levels of support for marijuana legalization. The poll reported that 60% of participants support cannabis legalization which is up from 12% when it was first conducted in 1969.

8. The DEA denied the rescheduling of cannabis in early August and then added cannabidiol to its list of Schedule I substances.

9. Colorado surpassed $1 billion in legal cannabis sales so far this year. This number does not include the amount of legal cannabis sold in November and December. Colorado is expected to sell between $1.2 and $1.3 billion in legal cannabis this year.

10. The first cannabis-related Real Estate Investment Trust (REIT) conducted an initial public offering on the New York Stock Exchange. Last week, NYSE-traded Innovative Industrial Properties (IIPR) completed the acquisition of PharmaCann’s 127,000 square foot medical cannabis cultivation and processing facility in New York.

Important Investor Disclosures

Disclosure. Compensated Affiliate. This report was authored by and is property of StoneBridge Partners LLC. All information and data relied upon in drafting this report is publicly available. The author believes and considers its sources to be reliable, but does not guarantee the accuracy or completeness of any information contained in this report. Any and all information, data, analyses and opinions are provided for informational purposes only and is not intended, in any manner, as investment advice. Any projections or other information generated by StoneBridge Partners LLC regarding the likelihood of various investment outcomes are hypothetical in nature, do not reflect actual investment results, and are not guarantees of future results. None of the material contained in this report is intended as a solution or offer to sell or purchase a specific stock or any other investment. This report is not directed to, or intended for distribution or use by, any person or entity that is a citizen, resident or located in any municipality, state, country or other jurisdiction where the distribution, publication, availability, or use of this report is contrary to any governing law or regulation. The securities discussed in this report may not be eligible for purchase and/or sale in certain jurisdictions or by particular individuals. It is important that you check any and all governing laws and/or regulations that may be applicable in your jurisdiction. Investing in securities of issuers organized outside of the United States, including ADRs, entail certain risks. The securities of non-United States issuers may not be registered with, nor be subject to the reporting requirements of the United States Securities and Exchange Commission. Please contact a Financial Advisor for professional advice regarding any and all securities investments. This report is intended for informational purposes only. StoneBridge Partners LLC’s officers, directors, employees, affiliates, or subsidiaries may have positions in securities covered by StoneBridge Partners LLC. StoneBridge Partners LLC receives compensation from the company and/or has a position in the securities mentioned in this report

 

Authored By: Michael Berger

To see more articles like this click the “LINK

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CBD (Cannabidiol) is typically used for medical reasons instead of recreational purposes like getting high. The CBD products are either derived from hemp or cannabis plants. The Hemp Business Journal estimated that the CBD market will grow to a $2.1 billion market in sales by 2020. That’s a 700% increase from 2016. In 2015, the CBD market brought in a total of $202 million.

“In terms of the CBD market size, I estimate an almost $3 billion market by 2021. Right now there are fifteen states that allow CBD only, in addition to the 28 states that have legalized medical marijuana,” Matt Karnes of Greenwave Advisors stated.

There are over 800 CBD products being sold, according to Headset Research data in Washington. Most labels on these products are intentionally light on details so it can be difficult for consumers to choose products right for them. Since 2013 the market has greatly changed. Customers were paying $1.25 for a milligram 4 years ago. Now the prices have decreased to an average of 3 cents per milligram and the quantities have increased. However, heightened competition and the price reductions cut their sales figures in half even though their customer numbers have increased.

Medical Marijuana says its products are derived from hemp plants grown in Austria. They also own a company that develops a line of products, such as a 1,000 milligram pill made of CBD that is geared towards athletes that have to avoid products containing THC. The venture capital firm General Hemp, another business leader, made $34 million in CBD sales in the last three years. Another industry leader, Axim Biotechnologies holds a license for a CBD chewing gum which they received a patent for recently.

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Right after the DEA decided to classify cannabis extracts (in particular classifying CBD, hemp and all their derivatives as Schedule 1 substances), the Hemp Industries Association (HIA) stated Monday that it’s “strongly considering legal action” to stop the DEA’s move.

The HIA is saying that CBD products should be classified as “supplements,” not drugs or pharmaceuticals. They said the DEA abused its authority. Stating that Congress or the U.S. attorney general are the only ones authorized to add CBD oil to the list of banned substances.

The non-profit trade association who represents businesses, farmers, researchers and investors working with industrial hemp, stated in a press release that the DEA was not right in classifying all CBD products as “marijuana extracts” considering the oil can be made from both marijuana and hemp plants.

“Additionally, the ruling is based on an incorrect and incomplete understanding of how CBD is derived from the cannabis plant,” the HIA said in a statement. “While CBD may be derived from forms of cannabis that contain high amounts of THC, the cannabinoid associated with ‘marijuana,’ CBD may also be produced from industrial hemp plants that meet the legal standards of less than 0.3 percent THC by dry weight, and which may be cultivated in 32 states in the U.S. per Sec. 7606 of the Farm Bill. Hence, not all CBD products may be classified as extracts from ‘marijuana.’”

Executive director of HIA; Eric Steenstra, says that Congress already ruled on the subject when they allowed hemp farmers to produce CBD oil in a bunch of states under the 2014 farm bill.

Steenstra reiterated that the “DEA has no authority whatsoever to impede the production, processing or sale of hemp products, including CBD products, grown under the Farm Bill.”

In the meantime; a finding presented by researchers at the American Epilepsy Society’s 70th Annual Meeting in early December discovered that CBD oil reduces the amount and severity of seizures in children and adults with severe, intractable epilepsy.

“Our research adds to the evidence that CBD may reduce frequency of seizures, but we also found that it appears to decrease the severity of seizures, which is a new finding,” said Jerzy P. Szaflarski, M.D., Ph.D., professor in the department of neurology and director of the Birmingham Epilepsy Center at the University of Alabama, who was at the meeting.

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