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Patient Advocate since 1977.


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“It’s California in 1995 All Over Again, Man” – Opportunities and Problems Piling Up in the European Cannabis Market – from Cannabis Business Executive magazine / Philip J. Cenedella IV

“It’s California in 1995 all over again, man.”

That was a comment I overhead during a conversation between an American and a German entrepreneur at the Mary Jane Berlin event held in Berlin in the second week of June, 2017.

Indeed, there may not be a better way to sum up the current state of the state here in Europe’s most populous country. Having been on the frontlines of the grassroots efforts in San Diego last century, it is fun to see how our industry is now growing in Germany and throughout Europe.  And like California back then, or now, the struggle is not always easy.

Here’s another interesting quote of the month:

“European markets are increasingly important to the cannabis sector. Each has a well-funded medical system, residents who seek natural and complementary therapies, and a government-supported mandate to stop the rising tide of opiate addiction related to chronic pain treatment.”

-Benjamin Ward, CEO, Maricann Group, Inc.

As of August, 2017 starts, the medical marijuana patients in Germany are experiencing “sold out” conditions nationwide, and the two exclusive importing countries (Canada and the Netherlands) are anticipating further bottlenecks as their in-country supply needs change. This is a significant problem – but also an opportunity for GMP-certified growers to fill the gap. If, and how, the German government opens up alternative supply to support their medical patients will be the top story in Germany this year.

From the patients perspective, there are two bad things about the current state of affairs: Little to no choice in their required medicine and their insurance companies are now refusing to cover the costs for the medicine as stipulated in the federal law.

Of course, lawyers are now getting involved and insurance companies are starting to be forced into approving valid claims from their policy-paying customers. But it is a silly, slow process to say the least.

The solution the German government is pursuing is to award 10 grow licenses to companies that will then produce 200 lbs. cannabis ​each within the country. The first bud from those plants are not scheduled to be picked until sometime in 2019, which is simply too long for patients to wait.

Some of the companies that have been publicly mentioned as potential winners of a grow license are Spektrum Cannabis, which is the Canopy Growth company formerly known as MedCann; Maricann GmbH, which is the new German subsidiary of its Canadian parent, Bedrocan, that has been a leader in the industry but recently run into a dispute with their Canadian licensee, Bedrocan International; Aurora Cannabis from Canada, which recently acquired the German firm Pedianos adding an EU-wide, medical marijuana distribution capability; and ABCann of Canada, which touts the “Father of THC” Dr. Raphael Mechoulam as a key member of their board of directors.

Homegrow options in Germany are currently not permitted, and existing indoor/outdoor farm operations are not yet able to be registered, licensed and taxed.

The black market continues to win, and patients continue to lose.  Cannabis business executives worldwide need to effectively work with the German government to develop the solutions we all know exist.  Three organizations that are key to this effort are the BfArM (www.bfarm.de )  the DHV (www.hanfverband.de )  and the GTAI ( www.gtai.de )

My personal comment is the government, politicians and regulators here in Germany need to listen to their constituents who support our industry by over 60 percent nationwide, according to a recent poll. The total quantity of flower to be delivered by the 10 licensees is probably less than what my buddy Butch has in his building back in California to handle his patients which live within five miles of the office.

Yes I am joking, Butch usually has less, but the point is – ​it simply is not enough for a population twice the size of California.

With all the talk about Germany, it is also important to remember that it is one of 18 countries within Europe that currently allow for some form of medical marijuana.  Besides Germany, there are provisions for the distribution and use of medical products in Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Israel, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and, the most recent addition, Poland.

This is an interesting list that, again, shows these are historic times here in Europe.

Sadly missing from the list above is the United Kingdom, and that has affected people we know. Our friend Vera Twomey, and her entire family had to leave the U.K. last month just to take care of their young daughter with Dravet’s Syndrome. In the U.K. their daughter suffered from up to 30 grand mal seizures a day while taking a regimen of pharmaceutical drugs.

Think about that for a moment – 30 grand mal ​seizures a day.

Now living as “medical refugees” from their homeland, the Twomey’s and their daughter are now dealing with zero grand mal seizures a day thanks to her medical marijuana.

30 grand mal seizures a day, now zero a day – everyday for the past 3-4 weeks.

The United Kingdom calls medical marijuana illegal. Patients and advocates call that thinking arcane, unjust, and possibly criminal itself. They are now petitioning the Human Rights Commission of the European Union in Brussels for help. I am positive their efforts will be successful – it is just a matter of time.

Vera and her family hope it comes within her daughter’s lifetime. That is all for now. Have a successful rest of the summer, rest up and get ready because I believe that Q-4 of 2017 is going to be a busy one for our industry and your company.

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Police in Berlin arrest Medical Marijuana patient (with prescription) at Berlin Hemp Parade. “What a long strange trip its been”…..continues.

Leider war weder die ein…

  • 24 a road transport law (consequence)
    (2) irregular acts as a vehicle for the use of a motor vehicle by means of a motor vehicle as defined in the annex to this regulation. Such an effect occurs when a substance specified in this annex is detected in the blood. The first sentence does not apply if the substance comes from the intended use of a medicinal product prescribed for a specific case.Unfortunately, neither the police on the hemp parade nor the responsible public prosecutor and judges have been able to read and understand these rather simple paragraphs.

Our very experienced and good truck driver has been forced to pay for blood collection before the start of the parade, because it is prescribed for cannabis by the doctor. After several hours of discussion. Not nice, not correct, and also bad for road safety!

cops

 


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Dr. Franjo Grotenhermen, on of the world’s preeminent medical cannabis experts, has announced a hunger strike until Germany sufficiently opens up the medical cannabis program to all patients in need. –

franjo

German Cannabis Expert Announces Hunger Strike

Germany has made great strides improving its cannabis laws in recent years, but there is still so much work to be done, as too many patients are still without safe access to a safe medicine. There was understandably great hope that Germany would start treating marijuana the same as any other medicine, after the country implemented an expansion of the burgeoning medical program, but too many bureaucratic hurdles remain. Hoping to fulfill the practical notion that cannabis should be treated the same as any other prescribed medicine, Dr. Franjo Grotenhermen, on of the world’s preeminent medical cannabis experts, has announced a hunger strike until Germany sufficiently opens up the medical cannabis program to all patients in need.

I had the honor of meeting Dr. Grotenhermen when he spoke at the International Cannabis Business Conference in Berlin last year, and the man’s dedication to the cause, and expert knowledge, were evident to all in attendance. I hope when the ICBC returns to Berlin in 2018, that Dr. Grotenhermen can reflect on how his efforts have successfully brought medical cannabis fully into the medical mainstream.

Below is a press release sent out by Dr. Grotenhermen announcing his hunger strike: 

Cannabis expert starts hunger strike

Rüthen: On August 17, 2017, the German cannabis expert Franjo Grotenhermen entered an indefinite hunger strike. The objective of refusing to accept any food is to decriminalize all citizens who need cannabis to treat their serious diseases.

On March 10, 2017, a much-debated law on cannabis as a medicine went into effect in Germany. It was the declared aim of the legislature to allow all patients who need a therapy with cannabis medicines to do so. The law, however, proves itself in practice as too bureaucratic. Therefore, treatment with cannabis and cannabinoids is unattractive for doctors who in principle support such therapy. Many patients do not find a doctor who allows them legal access to the needed treatment.

“The legislature has taken a great step into the right direction,” explains Grotenhermen. “However, many patients are still dependent on a still as illegal regarded treatment. They face criminal sanctions. This is no longer acceptable. Therefore a basic clarification in the narcotics law must be established. The prosecution of patients to whom a doctor has certified the need for a therapy with cannabis must end. ”

Already today, the German Narcotics Law allows prosecutors to stop a criminal case in the case of a “minor debt”. This possibility is mainly applied in cases of possession of small amounts of cannabis. Grotenhermen urges that criminal proceedings should in principle also be stopped if accused citizens need cannabis for medical reasons. “The need for a cannabis therapy should not be judged by the judiciary, a government agency or a health insurance company, but, as with other medical treatments, also by a doctor,” explains Grotenhermen.

He also strongly supports the uncomplicated access of patients to standardized preparations from the pharmacy. In this respect, it is necessary to improve the existing law. However, the prosecution of the remaining losers of the legal situation must also be ended. “I am not aware of a convincing argument by which patients’ prosecution can be maintained,” adds Grotenhermen. A corresponding amendment to the Narcotics Act is, therefore, logical and unavoidable.

From 7 pm a 21-minute video will be presented on a special website (www.cannabis-hungerstrike.de), in which Grotenhermen explains in detail the background and goals of his hunger strike. On May 12, 2017, he had already begun a short 8-day “warning hunger strike”, by which he wanted to draw attention to a problem associated with the new law.

Franjo Grotenhermen, born in 1957, studied medicine in Cologne. Medical practice in Rüthen (NRW) with a focus on therapy with cannabis and cannabinoids. Grotenhermen is the chairman of the German Association for Cannabis as Medicine (ACM), Executive Director of the International Association for Cannabinoid Medicines (IACM) and
Chairman of the Medical Cannabis Declaration eV (MCD), as well as author of the IACM-Bulletin, which is available in several languages on the website of the IACM. Grotenhermen is an associate of the Cologne nova-Institut in the department of renewable resources and author of numerous articles and books on the therapeutic potential of the hemp plant and cannabinoids, their pharmacology and toxicology. Among others, since 2008 he has been an expert on debates in the
Health Committee of the German Bundestag on the medical use of cannabis products, most recently in September 2016.

Anthony Johnson

Anthony, a longtime cannabis law reform advocate, was Chief Petitioner and co-author of Measure 91, Oregon’s cannabis le 

http://marijuanapolitics.com/german-cannabis-expert-announces-hunger-strike/


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Canadian execs: What you need to know before taking your cannabis business global

(This is the fourth article of a four-part series examining how Canadian cannabis companies are expanding globally. Click to read Part IPart II and Part III.)

By Matt Lamers

There’s no denying the massive potential of the global medical marijuana market: A recent report pegged it at 180 billion Canadian dollars ($142 billion) over the next 15 years.

But going overseas is fraught with pitfalls, barriers and red tape. Canadian MMJ businesses, however, are export pioneers and can offer valuable guidance.

To capitalize on the global medical cannabis market, about a dozen Canadian MMJ companies are using exports as an avenue to strike local partnerships in foreign markets as well as establish licensing arrangements and distribution deals.

Six top executives at Canadian cannabis companies shared their insights with Marijuana Business Daily on where they look to expand their businesses, how they find local partners, and why they go overseas in the first place. They also talked about the contacts you need to expand abroad.

Neil Closner, MedReleaf CEO

Who: You need to find good people. Without that, any company will fail. Specifically in this space, there’s a lot of complexities – dealing with regulators, dealing with growing live plants, dealing with production process issues. You really need to trust and rely on your people. Otherwise you get tripped up. So anyone starting out should make sure they have the right complements of skills and staff.

Where: We look for markets where it’s regulated at a federal level. The fact that most of these markets are going medical only, and it’s even more strictly regulated from a medical standpoint than we are here in Canada, plays to our strength. As the only ISO- and ICH-GMP certified producer in North America, that level of rigour that we bring to the industry plays well for us.

We look at markets based on size, what the distribution’s going to look like, who the buyers are going to be, if there’s insurance coverage.

Aaron Keay, ABcann Global CEO

How: You’ve got to get on the ground over there and spend some time with the agencies and companies that are already there. That way you can build a relationship and start discussing things like collaborations and joint ventures first. We have a presence in (other) countries, but it didn’t happen overnight. We navigated through it with consultants and government officials over time before we got into a position where we now feel comfortable enough to say, “Okay, we can do some business here.”

Marc Lustig, CannaRoyalty CEO

When: Typically the math will end up being an indicator. We’ve seen management teams take on more than what is possible with time, resources and capital. A proper plan that is focused is essential. It’s very easy to build a bridge to the middle of a lake. Before you have grandiose designs on expanding into other markets, you would have to understand the compliance and licensing constraints in that market.

George Scorsis, Liberty Health Sciences CEO

Why: If we’re entering into a system, we need to ensure that we validate the rationale for why we’ve entered into the market, and that it’s to further enhance the medical system. Second, it also insulates us from potential federal interactions.

Strictly look at medical platforms prior to looking at anything recreational or adult use.

Who: Ensure that you partner with people that have great local knowledge.

Cam Battley, executive VP of Aurora Cannabis

Where: It has to be federally legal. We’ve got to make sure that everything we do it kosher with the (Toronto Stock Exchange). I’m very interested in the U.S. market, but I’m not going there until it’s federally legal.

Who: We’re looking for serious people. They have to bring a series of important things to the table. Pedanios (a German distributor) is a good example. They’ve already demonstrated they know what they’re doing through Pedanios’s role as a medical cannabis distributor.

Dooma Wendschuh, Province Brands CEO

Where: One thing we look for when we get to scale is: Let’s find one of the countries in Europe that have legalized medical marijuana and let’s find a suitable partner with whom we can work to build a brewery (the company makes alcohol-free beer using marijuana) in their country so that we don’t have to ship it across the Atlantic. Shipping costs are important to take into account.

The comments have been edited for length and clarity.

Matt Lamers can be reached at mattl@mjbizdaily.com

Daily News | Canada Marijuana News | Cultivation | Featured


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Canadian exports of medical marijuana soar as producers seek overseas toehold

(This is the third article of a four-part series examining how Canadian cannabis companies are expanding globally. Part I was published Aug. 9 and Part II on Aug. 10. Part IV will publish Wednesday.)

By Matt Lamers

Canadian medical cannabis exports are surging, driven by licensed producers that are using overseas shipments as a way to establish local partnerships and gain a foothold in foreign markets.

In particular, exports of dried medical marijuana and MMJ oil products from Canada have soared since 2015.

And they are on pace to double this year from 2016 levels, according to data obtained by Marijuana Business Daily. Analysts expect this trend to continue in the near future as more countries legalize medical cannabis.

While exports remain a sliver of overall medical marijuana sales in Canada, licensed producers (LPs) have moved to capitalize on burgeoning overseas MMJ markets such as Germany, Australia and South America.

According to data from Health Canada, the government body responsible for issuing cannabis export permits:

  • Just over 45 kilograms (100.3 pounds) of dried cannabis and 94.7 kilograms of cannabis oil were exported through July 20 of this year.
  • For all of 2016, 44.8 kilograms of dried cannabis and 100.8 kilograms of cannabis oil were shipped overseas.

No medical marijuana was exported in 2015 under the former Conservative government, which did not share the pro-MJ views voiced by current Prime Minister Justin Trudeau.

Cam Battley – a member of the board of directors of Cannabis Canada, the industry association for licensed producers – sees exports as a means to an end.

“We’re going to see exports to multiple new legal medical cannabis markets soar,” he said, “but ultimately the real game is going to be building and owning capacity in new markets.”

How it breaks down

Over the past two years, Canadian LPs have exported cannabis oil to Australia, the Cayman Islands, Chile, Croatia, Cyprus, the Czech Republic and New Zealand. Dried cannabis has been sent to Australia, Brazil, Germany, Israel and the Netherlands, according to Health Canada.

No cannabis export permits were issued in 2015, while 43 were handed out last year and 75 as of July 20 this year.

Of the 75 permits issued this year, 11 were for dried cannabis and 64 for cannabis oil products.

In total, 118 export permits were issued by Health Canada as of July 20 under federal guidelines established between 2013 and 2016.

The data also shows that most export applications were approved.

In 2016, Health Canada received 11 export applications for dried medical cannabis and issued nine permits.

So far this year, Health Canada has approved 11 of 13 export applications submitted for dried MMJ.

Though growing quickly, exports still represent a tiny fraction of overall MMJ sales by the country’s licensed producers.

In the first three months of 2017, slightly less than 6,000 kilograms of dried medical cannabis were sold to 129,876 registered clients across Canada for medical use, meaning exports accounted for less than 1% of all sales.

Examples of Canadian exporters

To give their marijuana sales a shot in the arm, several Canadian licensed producers have turned to the export market:

More export growth anticipated

Looking ahead, analysts expect exports will continue to rise as Canadian LPs service niche markets and establish localized operations abroad.

Khurram Malik, a partner with financial advisory firm Jacob Capital Management, sees exports spiking to certain nations and regions before coming back down once Canadian LPs set up operations in those markets.

“Exports will be larger from where they are today, but I don’t think they will be a large part of the revenue mix (for Canada’s LPs) going forward,” he said, owing to the high costs of growing cannabis in Canada. “Canada won’t be cost competitive with markets overseas for exports.”

Battley, the Cannabis Canada board member, sees exports climbing in response to new markets coming online. Twenty-three countries have active medical cannabis laws, while another 14 countries have pending laws, not counting the United States.

“What we’ve seen thus far is a trickle,” he added. “Germany’s intention, for example, is to have licensed producers from other jurisdictions supply the market until 2019, hoping that by then there will be sufficient domestic capacity. But building and licensing high-quality capacity takes time.”

Matt Lamers can be reached at mattl@mjbizdaily.com

Daily News | Canada Marijuana News | Cultivation | Featured


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Canada’s medical marijuana market has experienced explosive growth, particularly for extracts. The amount of cannabis oil sold to clients registered with Health Canada rose 870% between the first quarter of 2016, when 584 kilograms were sold, and one year later, when 5,673 kilograms were sold.

Canada-recreational-marijuana-web-e1501023238758

 

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Banks versus pharmacists – first official extortion in the public drug scene – URUGUAY – by HANF JOURNAL .de

https://hanfjournal.de/2017/08/18/apotheken-in-uruguay-werden-aufgrund-legalen-hanfhandels-von-banken-verschmaeht/

uy

After moving forward in Uruguay in order to keep the own population of black market traders of illegal substances , unexpected hurdles seem to arise in the first country of the re-legalization of cannabis. The pharmacies in Uruguay are scorned by legitimate hemp trade by banks and have to fear their hitherto maintained money accounts. Either the cannabis sale would be discontinued, or abandoned to the formerly valued customer, it says on the side of the money institutions.

The President of the State Banco de la República, Jorge Polgar, said that no relations with pharmacies would have been accepted which would have received a license for the trade in marijuana . This is to prevent the international isolation of the bank which would actually be possible due to cross-border activities of the domestic financial institutions in the USA. According to international regulations, no accounts should be kept which are connected in any way to drug trafficking. Even if the government in Uruguay does not provide criminal prosecution for the public trade in cannabis – even behind the state’s distribution – the banks of the brave country feel their hands bound to international law.
In the absence of a solution to the surprising tangle mill in Uruguay, many of the twenty approved pharmacies would have to end their trade with the coveted and extremely affordable natural substance . A threatened blocking of his own bank account forced the medication-offering businessmen to the reluctant action, explained a lawyer of the pharmacist settlement of Uruguay.

Banks versus pharmacists – first official blackmail attempts in the public drug milieu!

 

 

 


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ALGAE DYNAMICS CORP ENTERS INTO A LETTER OF INTENT WITH BONIFY TO PRODUCE UNIQUE CANNABIS OIL PRODUCTS; ACCELERATES GO-TO-MARKET STRATEGY

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ALGAE DYNAMICS CORP ENTERS INTO A LETTER OF INTENT
WITH BONIFY TO PRODUCE UNIQUE CANNABIS OIL PRODUCTS;
ACCELERATES GO-TO-MARKET STRATEGY

TORONTO--August 16, 2017--ALGAE DYNAMICS CORP (OTCQB: ADYNF) (the "Company"), a
company focused on the development of unique health products and pharmaceuticals utilizing cannabis
and algae oils, today announced that it has further refined its relationship with 6779264 Manitoba Ltd dba
Bonify (“Bonify”) in a Letter of Intent (“LOI”) dated August 10, 2017. Bonify is a Licensed Producer,
pursuant to the Access to Cannabis for Medical Purposes Regulations in Canada, with the capability to
grow multiple strains of cannabis in its state-of-the-art 320,000 square foot facility.
The Company previously announced a Memorandum of Understanding with Bonify on May 9, 2017, in
which Bonify agreed to supply raw cannabis plant material for processing into cannabis oil for sale and
for use in research. In the recently completed LOI, the Company and Bonify have outlined the following:
1) The purchase and installation of cannabis oil extraction equipment by the Company in Bonify’s
facility;
2) The processing of cannabis material supplied by Bonify and other Licensed Producers in the oil
extraction facility;
3) The supply of cannabis oil and algae omega-3 oils to The University of Waterloo and University of
Western Ontario to support the Sponsored Research Agreements that the Company has in place with
the two universities; and
4) The sharing of direct expenses, and, after adjustment for the market value of cannabis material
supplied by Bonify and third parties, sharing of revenues from the sale of cannabis oil and algaecannabis
oil products.
The term of the agreement is for three years from the commencement of operations and is renewable by
mutual agreement. The Company and Bonify agree to use best efforts to complete formal documentation of
the agreement by September 30, 2017. Upon termination of the agreement, the Company agrees to transfer
title of the equipment to Bonify. The Company has engaged investment bankers to assist with the raising of
necessary capital to purchase and install the extraction equipment.
Given the favorable terms of this agreement, the Company does not anticipate moving forward with its
previously announced joint venture with ARA – Avanti Rx Analytics Inc. in which it was contemplated that
oil extraction would be done utilizing the latter’s facility.
Assuming that all regulatory approvals are in place, initial revenues are expected within six to nine months
following completion of financing,
Paul Ramsay, Chairman and President of Algae Dynamics Corp, stated, “We believe this Letter of Intent
gives us an improved pathway to early revenues as well as a reliable high-quality source of cannabis oil for
the universities to support our important algae-cannabis oil research. We look forward to expeditiously
completing this agreement.”
Jeff Peitsch, President and CEO of Bonify, commented, “Our team is pleased to be working with Algae
Dynamics Corp in support of the Company’s ongoing research and product development work with
universities. We see many benefits to working together with innovative companies such as Algae Dynamics
in this burgeoning cannabis market.”
About Bonify
Bonify is a Canadian-owned Licensed Producer and leading provider of medical cannabis. By maximizing
research findings and strictly adhering to best-in-class practices, quality standards and procedures, Bonify
produces medical cannabis products to help individuals get the most out of life each and every day. With
over 1,000,000 square feet of potential productive capacity at its present site in Winnipeg, Manitoba, Canada,
when at full scale, Bonify will be capable of growing over 100,000 kgs of cannabis annually.
About Algae Dynamics Corp
ADC is engaged in the development of unique health products and pharmaceuticals that utilize hemp,
cannabis and algae oils. We have engaged two Canadian universities to provide research into the use of
extracts from cannabis oil, which we plan to use to develop products that combine the significant health
benefits of Omega-3s derived from algae oil and extracts from cannabis oil. Our research is focused on the
use of cannabis oil in the context of cancer, and the use of cannabis derivatives for the development of novel
pharmacotherapies for mental health.
For more information, visit http://www.algaedynamics.com
FORWARD-LOOKING STATEMENTS
This news release contains "forward-looking statements" as that term is defined in Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press
release which are not purely historical are forward-looking statements and include any statements regarding
beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include,
among other things, use of proceeds and the development, costs and results of current or future actions and
opportunitiesin the sector. Actual results could differfrom those projected in any forward-looking statements
due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new
projects and development stage companies, our ability to raise the additional funding we will need to
continue to pursue our exploration and development program, and our ability to retain important members
of our management team and attract other qualified personnel. These forward-looking statements are made
as of the date of this news release, and we assume no obligation to update the forward-looking statements, or
to update the reasons why actual results could differ from those projected in the forward-looking statements.
Although we believe that any beliefs, plans, expectations and intentions contained in this press release are
reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove
to be accurate.
Investors should consult all the information set forth herein and should also refer to the risk factors disclosure
outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form
10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
INVESTOR RELATIONS CONTACT:
Jack Eversull, President
The Eversull Group, Inc.
jack@theeversullgroup.com
972-571-1624
COMPANY
CONTACT:
Paul Ramsay, President
Algae Dynamics Corp
ramsay@algaedynamics.com
416-704-3040

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FDA ISSUES CALL FOR COMMENT!! International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments

Featured Image -- 866

Action

Notice.

Summary

The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).

Dates

Submit either electronic or written comments by September 13, 2017.

Addresses

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 13, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand Delivery/Courier (for Written/Paper Submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-4515 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil; Furanyl fentanyl (Fu-F); Acryloylfentanyl (Acrylfentanyl); Carfentanil; 4-fluoroisobutyrfentanyl (4-FIBF); Tetrahydrofuranylfentanyl (THF-F); 4-fluoroamphetamine (4-FA); AB-PINACA; AB-CHMINACA; 5F-PB-22; UR-144; 5F-ADB; Etizolam; Pregabalin; Tramadol; Cannabidiol; Ketamine; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For Further Information Contact

James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: james.hunter@fda.hhs.gov.

Supplementary Information

I. Background

The United States is a party to the 1971 Convention on Psychotropic Substances (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (the U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion.

Section 201 of the CSA (21 U.S.C. 811) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.

II. WHO Notification

The Secretary of HHS received the following notice from WHO (non-relevant text removed):

Ref.: C.L.xx.2017

The World Health Organization (WHO) presents its compliments to Member States and Associate Members and has the pleasure of informing that the Thirty-ninth Expert Committee on Drug Dependence (ECDD) will meet in Geneva from 6 to 10 November 2017 to review a number of substances with potential for dependence, abuse and harm to health, and will make recommendations to the U.N. Secretary-General, on the need for and level of international control of these substances.

At its 126th session in January 2010, the Executive Board approved the publication “Guidance on the WHO review of psychoactive substances for international control” (EB126/2010/REC1, Annex 6) which requires the Secretariat to request relevant information from Ministers of Health in Member States to prepare a report for submission to the ECDD. For this purpose, a questionnaire was designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control for each substance under evaluation. Member States are invited to collaborate, as in the past, in this process by providing pertinent information as requested in the questionnaire and concerning substances under review.

It would be appreciated if a person from the Ministry of Health could be designated as the focal point responsible for coordinating and answering the questionnaire. (non relevant information from letter not shown, see letter for text not shown here) The designated focal point, and only this person, should access and complete the questionnaires:

1. Ocfentanil

2. Furanyl fentanyl (Fu-F)

3. Acryloylfentanyl (Acrylfentanyl)

4. Carfentanil

5. 4-fluoroisobutyrfentanyl (4-FIBF)

6. Tetrahydrofuranylfentanyl (THF-F)

7. 4-fluoroamphetamine (4-FA)

8. AB-PINACA

9. AB-CHMINACA

10. 5F-PB-22

11. UR-144

12. 5F-ADB

13. Etizolam

14. Pregabalin

15. Tramadol

16. Cannabidiol

17. Ketamine

PDF versions of the questionnaire in English, French and Spanish may be downloaded from the link http://www.who.int/medicines/access/controlled-substances/ecdd/en/. Please note that these versions are for reference only and all questionnaires must be answered through the online system. Further clarification regarding the questionnaire may be obtained from the Secretariat by emailing: ecddsecretariat@who.int.

Replies to the questionnaire must reach the Secretariat by 30 September 2017 in order to facilitate analyses and preparation of the report before the planned meeting. Where there is a competent National Authority under the International Drug Control Treaties, it is kindly requested that the questionnaire be completed in collaboration with such body.

The summary information from the questionnaire will be published online as part of the report on the Web site for the Thirty-ninth ECDD linked to the Department of Essential Medicines and Health Products (EMP). The provisional agenda of the Thirty-ninth ECDD and the list of psychoactive substances under review are also published on Thirty-ninth ECDD Web page: http://www.who.int/medicines/access/controlled-substances/ecdd/en/.

Member States are also encouraged to provide any additional relevant information (unpublished or published) that is available on these substances to: ecddsecretariat@who.int. This information will be an invaluable contribution to the ECDD and all submissions will be treated as confidential.

The World Health Organization takes this opportunity to renew to Member States and Associate Members the assurance of its highest consideration.

GENEVA, 7 July 2017

FDA has verified the Web site addresses contained in the WHO notice, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

III. Substances Under WHO Review

Ocfentanil is a synthetically produced opioid that is structurally related to fentanyl and approximately equipotent in effect. Reported risks associated with use of ocfentanil include development of opioid use disorder, overdose, and fatal overdose. It has no approved medical use in the United States and is not a controlled substance in the United States under the CSA.

Furanyl fentanyl (Fu-F) is a potent clandestinely produced synthetic opioid that is an analog of fentanyl. Evidence suggests that the pattern of abuse of fentanyl analogues, including furanyl fentanyl, parallels that of heroin and prescription opioid analgesics. Fu-F produces the typical opioid effects that include respiratory depression and loss of consciousness. Seizures of Fu-F have been encountered in powder form. Fu-F has been connected to fatal overdoses, in which intravenous routes of administration are documented. It has no approved medical use in the United States. On November 29, 2016, the Drug Enforcement Administration (DEA) issued a final order to temporarily schedule Fu-F and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into Schedule I pursuant to the temporary scheduling provisions of the CSA.

Acryloylfentanyl (Acrylfentanyl) belongs to the 4-anilidopiperidine class of synthetic opioids and is similar in structure to fentanyl. Acryloylfentanyl is a clandestinely produced analog of fentanyl and sold illegally as a research chemical on several Web sites. Acryloylfentanyl has also been associated with adverse events typically associated with opioid use such as respiratory depression, anxiety, constipation, tiredness, hallucinations, and withdrawal. The use of acryloylfentanyl has also been linked to the development of opioid use disorder, overdose, and fatal overdose. Acryloylfentanyl has no commercial or medical uses. On July 14, 2017, the DEA issued a temporary order to temporarily schedule acryloylfentanyl, its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I pursuant to the temporary scheduling provisions of the CSA.

Carfentanil, also known as 4-carbomethoxyfentanyl, is an extremely potent synthetic opioid that is similar in structure to and approximately 100 times more potent than fentanyl as an analgesic. At one time legitimately produced, carfentanil is no longer manufactured, marketed, or used in the United States; it is approved by FDA for use under restricted conditions by veterinarians as a immobilizing agent for certain large animals. Illicitly produced carfentanil is a particularly harmful fentanyl analogue that is also being laced into heroin or sold by itself and trafficked in the United States. It is not approved for human use. Drug seizure data indicate that carfentanil is typically used in small doses to cut heroin and other illicitly abused drugs. The significant risk to public health associated with carfentanil use stems from its respiratory depressive effects with very small amounts. Several fatalities have been reported as the result of carfentanil overdoses. On October 28, 1988, the DEA placed carfentanil in Schedule II of the CSA.

4-fluoroisobutyrfentanyl is a clandestinely produced synthetic opioid that is an analog of fentanyl. It has µ-receptor agonist activity similar to that of fentanyl. This would result in effects associated with opioid agonists such as analgesia, respiratory depression, anxiety, constipation, tiredness, hallucinations, withdrawal, the development of opioid use disorder, overdose, and fatal overdose. The use of 4-fluoroisobutyrfentanyl has been implicated in several cases of overdose and fatal overdoses. 4-fluoroisobutyrfentanyl has not been approved for medical use in the U.S. On May 3, 2017, the DEA issued a temporary order to temporarily schedule 4-fluoroisobutyrfentanyl, its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into Schedule I pursuant to the temporary scheduling provisions of the CSA.

Tetrahydrofuranylfentanyl (THF-F) is a synthetic opioid that is an analog of fentanyl. It has µ-receptor agonist activity similar to that of fentanyl, resulting in effects associated with opioid agonists such as analgesia, respiratory depression, anxiety, constipation, tiredness, hallucinations, withdrawal, the development of opioid use disorder, overdose, and fatal overdose. THF-F is not approved for medical use or controlled in the United States under the CSA.

4-Fluoroamphetamine (4-FA) is a psychoactive substance of the phenethylamine and substituted amphetamine chemical classes and produces stimulant effects. WHO reports that 4-FA is clandestinely produced, and its use is associated with fatal and non-fatal intoxications. 4-FA was reviewed at the 37th ECDD (2015) and, while not placed under international control due to insufficient data, was kept under surveillance. 4-FA is not approved for medical use in the United States and it is not controlled under the CSA.

AB-PINACA is a clandestinely produced synthetic cannabinoid agonist approximately 1.5 times as potent as delta-9-tetrahydrocannabinol. Adverse effects produced by cannabinoid agonists include tachycardia, agitation, hallucination, chest pain, seizure, anxiety, acute psychosis, and death. AB-PINACA has been detected in illicit synthetic cannabinoid substances, and reported in cases of overdose and hospitalizations. It has not been approved for medical use in the United States. On January 27, 2017, the DEA published a Notice of Proposed Rulemaking to permanently control AB-PINACA as a Schedule I substance under the CSA.

AB-CHMINACA is a clandestinely produced synthetic cannabinoid agonist that is approximately 16 times more potent than delta-9-tetrahydrocannabinol. Adverse effects produced by cannabinoid agonists include tachycardia, agitation, hallucination, chest pain, seizure, anxiety, acute psychosis, and death. AB-CHMINACA has been detected in illicit synthetic cannabinoid substances and found in cases of overdose and hospitalizations. AB-CHMINACA has not been pre-reviewed or critically reviewed by the WHO. On January 27, 2017, the DEA published a Notice of Proposed Rulemaking to permanently control AB-CHMINACA as a Schedule I substance under the CSA.

5F-PB-22 is a synthetic cannabinoid agonist with similar effects to delta-9-tetrahydrocannabinol, one of the main psychoactive components of cannabis. Adverse effects produced by cannabinoid agonists include tachycardia, agitation, hallucination, chest pain, seizure, anxiety, acute psychosis, and death. 5F-PB-22 is clandestinely produced. It has been found laced on plant material and marketed as herbal products, and is smoked for its psychoactive effects. According to the WHO, 5F-PB-22 has been associated with fatal intoxications. On September 6, 2016, the DEA issued a final rule to permanently place 5F-PB-22 into Schedule I of the CSA.

UR-144 is a clandestinely produced synthetic cannabinoid agonist. In general, adverse effects produced by cannabinoid agonists include tachycardia, agitation, hallucination, chest pain, seizure, anxiety, and acute psychosis. UR-144 has been detected in herbal smoking blends that are sold as herbal incense. In June 2014, the 36th (2014) ECDD reviewed UR-144 and recommended that it be placed under surveillance. On May 11, 2016, the DEA issued a final rule to permanently schedule UR-144 into Schedule I of the CSA.

5F-ADB is a clandestinely produced synthetic cannabinoid agonist. In general, adverse effects produced by cannabinoid agonists include tachycardia, agitation, hallucination, chest pain, seizure, anxiety, and acute psychosis. 5F-ADB has been identified in overdose and/or cases involving death attributed to their abuse. Adverse health effects reported from incidents involving 5F-ADB and other synthetic cannabinoids have included: Nausea, persistent vomiting, agitation, altered mental status, seizures, convulsions, loss of consciousness, and/or cardio toxicity. On April 10, 2017, the DEA issued a temporary scheduling order to temporarily schedule 5F-ADB, its isomers, esters, ethers, salts and salts of isomers, esters, and ethers into Schedule I pursuant to the temporary scheduling provisions of the CSA.

Etizolam belongs to a class of substances known as benzodiazepines. Benzodiazepines produce central nervous system depression and are commonly used to treat insomnia, anxiety, and seizure disorders. Etizolam is currently prescribed in some countries to treat generalized anxiety disorder with depressive symptoms, but is not approved for medical use or controlled in the United States under the CSA. WHO reported that non-fatal intoxications that include cases of driving under the influence of drugs have been linked to etizolam. The ECDD at its 37th (2015 meeting reviewed etizolam and recommended that a critical review of etizolam is warranted.

Pregabalin is an anticonvulsant-type drug used to treat pain generated from the nervous system. It is available as an oral capsule and oral solution and approved for medical use in the United States for the management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, and adjunctive therapy for partial onset seizures, fibromyalgia, and neuropathic pain associated with spinal cord injury. Although the mechanism of action of pregabalin is unknown, studies in animals suggest that binding to the nervous system tissues may be involved in its pain-relieving and anti-seizure effects. Pregabalin binds with high affinity to the alpha 2-delta receptor site (a subunit of voltage-gated calcium channels) in the central nervous system. The binding of pregabalin at this site is thought to be responsible for its therapeutic effect on neuropathic pain. Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses. Pregabalin is a Schedule V controlled substance in the United States under the CSA.

Tramadol is an opioid analgesic that produces its primary opioid-like action through an active metabolite referred to as the M1 metabolite (O-desmethyltramadol). Tramadol was first approved for marketing in the United States in 1995 and is available as immediate-release, extended-release, and combination products for the treatment of moderate to moderately severe pain. On July 2, 2014, the DEA published a final rule in the Federal Register controlling tramadol as a Schedule IV substance of the CSA effective from August 18, 2014. Tramadol was pre-reviewed by the ECDD at its 28th (1992) and 32nd (2000) meetings, and critically reviewed at the 33rd (2002) meeting and not recommended for international control but placed on surveillance. Tramadol was pre-reviewed again by the ECDD at its 34th (2006) meeting; however, the ECDD concluded that there was not sufficient evidence to justify a critical review. At the 36th (2014) meeting, the ECDD considered updated information on tramadol, but again concluded that there was insufficient evidence to warrant a critical review.

Cannabidiol (CBD) is one of the active cannabinoids identified in cannabis. CBD has been shown to be beneficial in experimental models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in three therapeutic areas, but no such products are approved by FDA for marketing for medical purposes in the United States. CBD is a Schedule I controlled substance under the CSA. At the 37th (2015) meeting of the ECDD, the committee requested that the Secretariat prepare relevant documentation to conduct pre-reviews for several substances, including CBD.

Ketamine is classified as a rapid-acting general anesthetic agent used for short diagnostic and surgical procedures that do not require skeletal muscle relaxation. It is marketed in the United States as a solution for injection. Ketamine is controlled in Schedule III of the CSA in the United States. It is not controlled internationally under the Convention on Psychotropic Substances or the Single Convention on Narcotic Drugs. The ECDD reviewed ketamine at its 34th (2006), 35th (2012), and 36th (2014) meetings. On March 13, 2015, the Commission on Narcotic Drugs (CND) decided by consensus to postpone the consideration of a proposal concerning the recommendation to place ketamine in Schedule IV of the Psychotropic Convention. The CND requested additional information from the WHO. The ECDD reviewed updated information at its 37th (2015) meeting and found no reason to recommend a new pre-review or critical review of ketamine that could potentially change its standing 2014 recommendation that ketamine should not be placed under international control.

IV. Opportunity To Submit Domestic Information

As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of HHS, invites interested persons to submit comments regarding the 17 named drug substances. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drug substances. HHS will forward a scientific and medical evaluation of these drug substances to WHO, through the Secretary of State, for WHO’s consideration in deciding whether to recommend international control/decontrol of any of these drug substances. Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain recordkeeping requirements on them.

Although FDA is, through this notice, requesting comments from interested persons, which will be considered by HHS when it prepares an evaluation of these drug substances, HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2018. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments, as required by section 201(d)(2)(B) of the CSA.

V. Electronic Access

Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

Dated: August 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17119 Filed 8-11-17; 8:45 am]
BILLING CODE 4164-01-P