MJ News for 08/18/2014

7greeneyes

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http://www.bostonglobe.com/metro/20...controversy/CBXbe3nIuEnLDUGCxN0y1O/story.html




(Massachusetts) Change at the top in bid for marijuana permits


Kevin Fisher, executive director of a company that won provisional licenses for two Massachusetts medical marijuana dispensaries in June, resigned his position this weekend after recent reports that he had wrongly claimed on the dispensary applications that he had a college degree.

“It is with a heavy heart that I have arrived at this decision,” Fisher wrote to the board of directors of New England Treatment Access Inc. “But given the current climate regarding the error I included in my resume, I feel that this action is necessary to ensure that [the company’s] mission to deliver the highest quality patient education and cannabis therapies continue unencumbered.”

The letter, dated Saturday, is the latest chapter in a high-stakes and increasingly contentious state process to select companies for coveted marijuana dispensary licenses.

New England Treatment Access is the only company to receive more than one of the 11 provisional dispensary licenses awarded by the state two months ago. Nine other applicants were knocked out of the running over questionable finances and for providing misleading information in a selection process riddled with controversy.

State health officials had let New England Treatment go forward with plans to open medical marijuana dispensaries in Northampton and Brookline, even though a company hired by the state to screen applicants had detected the missing degree problem in April. After the discrepancy about Fisher’s academic claims was reported by the Globe last week, the state put those licenses on hold.

In a separate letter to state regulators, also dated Saturday, the company’s chief financial officer, Arnon Vered, wrote that New England Treatment had accepted Fisher’s resignation. The letter assured the state that Fisher would no longer be a member, director, or officer of the company, and will have no role in its governance.

“We regret that the discrepancy in Mr. Fisher’s resume has caused a distraction from the mission of the Department of Public Health to provide qualifying patients with access to the highest quality dispensaries possible,” Vered wrote. “While we have confidence in Mr. Fisher’s expertise, experience, and achievements in Colorado, we understand that his mistake, though perhaps unintentional, was careless.”

Vered’s letter said that he would be assuming the role of executive director and chief operating officer of the company, positions that Fisher resigned.

State health department spokesman Dave Kibbe said in an e-mailed statement that his agency had received New England Treatment’s letter and is reviewing the company’s proposed management changes. He said the company’s two provisional licenses remain on hold, and he declined to comment further.

Fisher, the owner of a marijuana business in Colorado, had said on his application that he had earned a bachelor’s degree in psychology from Youngstown State University, but the school has no record of his receiving any degree.

When first asked about the degree discrepancy by the Globe earlier this month, Fisher said he thought he had been awarded a degree. After state regulators put the company’s licenses on hold, New England Treatment sent the state a letter last week saying that several life-changing events — the death of Fisher’s mother and his estrangement from his father — during Fisher’s final college semester so affected him that he couldn’t focus on whether he actually graduated.

In its latest letter to state regulators, the company said that its structure is not based on Fisher alone, but instead on a team that includes experts in a variety of fields, including patient education, security, and cultivation. The company, it said, “has already made deep investments in critical products and services that will be very beneficial to qualifying patients seeking access to the highest-quality therapies.”

It also said that the company is on track to be among the first to open dispensaries, due to its “hard work and significant investment.”

“Our cultivation and processing facility is just weeks away from being ready for inspection,” the letter said, “and we have budgeted to hire 50 new employees in the next six months.”

New England Treatment also told regulators that continuing to keep its two licenses on hold would have a “negative impact” on patients.

“It would also have an adverse effect on those communities counting on the economic benefits that will come with our cultivation and registered medical marijuana dispensaries in the form of jobs, spending, and, revenue,” the letter stated.
 

7greeneyes

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http://www.foxnews.com/health/2014/...a-product-looks-like-lip-balm-packs-big-kick/




Dangerous :eek: new marijuana product looks like lip balm, packs big kick:shocked:


Drug dealers are peddling a new marijuana product called Wax that looks and feels like lip balm and packs a kick equivalent to smoking 15-20 joints of weed.

Police in Roswell, Ga., discovered 80 grams of Wax during a recent drug bust. Roswell Police Officer Zachary Frommer told Fox 5 in Atlanta last week that the drug ring was selling the substance to high school students.

“It’s just an extra kick,” he said. “It gets ’em higher and it gets ’em higher faster. The 15-20 joints you smoke can equal a dose of the Wax.”

The marijuana concentrate, also known as Butter and Honeycomb, has the consistency of lip balm and is easy to conceal in lip balm jars. It can be eaten or smoked, using a bong or an electronic cigarette. It is made from the oils of marijuana plants and has a high level of THC -- the chemical that gets a user high.

Wax is also easy to make, but dangerous to handle.

“You’re getting a lot of home cooks, a lot of teenagers and others that are trying to make it at home,” Frommer told Fox 5. “And because of the things you need to use to make it, because they’re flammable and they’re combustible and you may end up blowing up your house or burning yourself.”

In April, DEA administrator Michele Leonhart told the House Appropriations Committee that abuse of Wax was increasing throughout the U.S.

"In 2013, the THC content of leaf marijuana averaged 14 percent, while the THC content of marijuana concentrates averaged 54 percent, with some samples reported as high as 99 percent," Leonhart said. "Highly flammable butane gas is used to extract the THC from the marijuana leaf, and has resulted in home explosions, injuries, and deaths.
 

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http://articles.sun-sentinel.com/20...juana-amendment-ben-pollara-medical-marijuana




(Florida) Ad war looms over medical marijuana


A burst of ads coming soon to TV screens in Florida will feature patients and doctors extolling the virtues of marijuana as a compassionate way to treat the sick and ease their pain.

The soft-sell campaign, a laid-back variation on the usual political pitch, is designed to promote a constitutional amendment on November's ballot to legalize medical marijuana.

Countering that message will be a rival set of ads warning that approval of the amendment would lead to widespread drug use, supplied by "pot docs" and "pot shops" at every turn.

The dueling ad campaigns will compete for attention amid political appeals from candidates for governor and other offices, adding to an expected deluge of election messages though late summer and early fall.

Neither side would say when its ads will start or how much it's planning to spend. But both sides are preparing to hit the airwaves with TV and radio spots while developing networks of campaign volunteers and delivering their messages on the Internet. It's not quite politics as usual.

"We're not in a partisan scrum. We're not in an attack-and-response mode," said Ben Pollara, campaign manager of United for Care, which is spearheading the marijuana amendment.

"We're just going to go out there and have people share their stories about how medical marijuana has affected them, or could have affected them, and their loved ones." The testimonials, he said, will come from patients, doctors and nurses.

He said 10,000 volunteers have signed up to help convey the message through phone calls, in-person talks and social media.

They will be pitching constitutional Amendment 2, which "allows the medical use of marijuana for individuals with debilitating diseases as determined by a licensed Florida physician."

A more limited alternative was approved by the Republican-run Legislature and signed by Gov. Rick Scott in June. It legalizes development and distribution of a non-euphoric strain of cannabis — dubbed Charlotte's Web — to help Florida residents who have cancer and other debilitating diseases.

Early polls indicate overwhelming public support for medical marijuana — by 88 percent in a statewide Quinnipiac University poll — but analysts expect a close vote on Amendment 2, which requires 60 percent approval to become law.

Opponents, including law-enforcement groups and Republican leaders, say the amendment is full of loopholes that could allow unscrupulous "pot docs" to recommend the drug for recreational users.

"The thing I would be concerned about is the ruse of medicinal marijuana for purposes of allowing people basically to buy a joint and smoke it," U.S. Sen. Marco Rubio, R-Fla., told Florida reporters this month.

Nonprofit groups that oppose the measure have banded together under the Don't Let Florida Go to Pot coalition, which provides speakers at public forums. A separate group known as Vote No on 2 will lead the ad campaign.

A sample ad already has popped up on the Internet. The video shows scenes of children walking past marijuana stores in California, big piles of pot and derelicts puffing on pipes.

"They say they just want to help the sick, but that's not the whole story," a narrator intones. These scenes are interspersed with commentary from experts, such as lawyers and cops, who support the theme "The Devil is in the Details."

"A vote for Amendment 2 is a vote for legalization of marijuana forever in the state of Florida," Grady Judd, president of the Florida Sheriffs Association, tells viewers.

The coming air war will bring the debate into Floridians' living rooms.

"There's certainly going to be enough spending to make it a salient issue, with both sides ramping up their ad buys," said Daniel Smith, political science professor at the University of Florida. He said this issue, highlighted by the ads, will prompt some voters to cast ballots who otherwise might not bother with a non-presidential election.

"It could turn out people who are not enamored of Republicans or Democrats but see this issue as important to them," Smith said. "They see the failure in Tallahassee to address this issue in any meaningful way and may be motivated to come to the polls."
 

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http://www.bostonglobe.com/metro/20...ge-campuses/4ncfYh2ZKqdoHjoECm4lEJ/story.html




In halls of academia, medical marijuana an unwelcome guest


Although medical marijuana has been legal in Massachusetts for nearly two years, many local colleges are putting out the message to students as the fall semester nears: You still can’t use it on campus, even if a doctor says it’s medicinal.

College administrators have reaffirmed policies banning the drug in all forms, and that includes for students who have a doctor’s recommendation. They say their hands are tied by federal regulations, which still classify marijuana as an illegal drug, and they worry that allowing cannabis use of any kind could lead to the loss of federal funding, including student financial aid.

“I’m scared I’m either going to go under-medicated and suffer physical consequences if I can’t use my medicine enough, or I’m going to face consequences from the school if I get caught,” said Max, an incoming Boston University freshman, who asked that his last name not be published for fear of being singled out by the college. He says he has certification from a Massachusetts doctor to use marijuana to treat gastrointestinal issues that cause significant weight loss and stomach pain.

Students caught using marijuana on campuses can face punishment ranging from a warning to expulsion.

But other medical marijuana patients and advocates say colleges are being overly cautious. Forbidding the use of a state-recognized, doctor-authorized medicine is unfair, unethical, and a detriment to students, faculty, and others who use the drug to treat ailments, they say.

“We would like to see schools recognize, as many states and millions and millions of individuals and doctors have done, that marijuana is in fact valid medicine for the patients that are using it, and treating it differently than other medications is harmful to students and faculty who have chosen to use medical marijuana,” said Betty Aldworth, director of Students for Sensile Drug Policy, a national student network pushing for an overhaul of drug laws.

The issue has gained attention locally as more formal patient certifications are set to become available in Massachusetts and as dispensaries are expected to open across the state within several months.

Some schools — including Boston University, Tufts University, and Amherst, Curry, Emerson, Hampshire, and Wheelock colleges — that ban medical marijuana on campus try to help students with certifications to find alternatives. One way is to allow the students to opt out of on-campus housing contracts and requirements so they can pursue treatment off-campus.

BU dean of students Kenneth Elmore said “a few” students with medical marijuana certifications have approached campus officials since the state voted to legalize medical use in Nov. 2012, asking whether the documentation allows them to use the drug on campus without repercussions. It does not, Elmore said. Those students are referred to campus health officials to privately discuss alternatives.

“We’d work with the student on that sort of thing,” he said.

But, Elmore added: “We don’t make a distinction between medical and recreational marijuana. We simply don’t allow marijuana on our campus. Federally, it is illegal, and smoking causes disruptions on campus.”

Advocates point out that medical marijuana can be consumed in other ways, including by vaporizing the drug, eating cannabis-infused foods and drinks, or even taking a pill containing marijuana’s active ingredient, THC.

The ban on cannabis use — medical or otherwise — also appears to be widespread at campuses across the other 22 states and Washington, D.C., where local laws permit patients with doctor-issued certifications to use the drug for treatment.

Thomas C. Burke Jr., 25, a student at Yale Divinity School who said he has a doctor’s certification to use the drug in Connecticut, says he has largely avoided problems by being discrete or by only using marijuana off campus.

Burke said his certification is to use the drug in Connecticut, where it became legal in 2012, to treat symptoms of post-traumatic stress disorder he has suffered since serving in combat zones in Iraq and Afghanistan.

“I try to make it as little of a distraction as possible and be as accommodating as I can to others,” said Burke, who supplements his use with cognitive therapy.

Still, colleges’ rules on medical marijuana cause uneasiness.

“For most veterans with PTSD, which is an anxiety disorder, the anxiety of having to worry about being penalized or seen as a criminal keeps them from medicating,” said Burke.

“We are not just doing drugs during the day, we are medicating ourselves, which allows us to be productive members of society.”

While numerous Massachusetts colleges have affirmed their bans in student and employee conduct policies, some campuses — including Eastern Nazarene and Mount Holyoke colleges — say they are weighing whether to revise their policies.

“It is unclear what impact, if any, a change in policy would have on federal funding,” said Jeffrey Kirksey, vice president for student development and retention at Eastern Nazarene, in Quincy.

That lack of clarity stems, in part, from mixed messages from federal officials.

The Justice Department said in a memorandum last year that it focuses enforcement on the most serious marijuana-related violations, and it is “not an efficient use of federal resources to focus enforcement efforts on seriously ill individuals, or on their individual caregivers.”

However, in 2011, the White House Office of National Drug Control Policy and the Education Department wrote a letter warning campuses that deviating from federal rules could put their federal funding at risk.

“The administration’s stance hasn’t changed since then,” drug control policy office spokeswoman Cameron Hardesty told the Globe last week.
Advocates, however, say it is unrealistic to believe the US government would cut off funding to colleges over the issue.

“I understand not wanting to risk millions of dollars in federal funding, but no college has ever lost federal funding for changing their drug or alcohol policies,”said Connor McKay, a 22-year-old Northeastern University senior and president of the campus chapter of Students for Sensible Drug Policy. “Colleges could and should at least accommodate students who need to use it.”
 

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http://www.nasdaq.com/article/legal...smuggling-crisis-in-the-great-plains-cm380875




Legalized Marijuana Ignites a Pot-Smuggling Crisis in the Great Plains


The legal weed business in Colorado is flourishing, with June pulling down sales of $24.7 million , the biggest month since legalization took hold in January. The state took in nearly $24 million in pot-generated revenue just through the month of May, according to the New York Times .
But, there's a dark side to Colorado's success, which features hordes of tourists inundating the state to purchase everything from the weed itself to marijuana-infused treats and beauty products.

In fact, it is the out-of-state visitors that are causing the rumpus - as they take cannabis products on the road with them, beyond the state borders of Colorado.

A homegrown traffic problem

Troubles are arising not from the fact that pot is legal in Colorado, but that it is still considered contraband in neighboring states, like Kansas and Nebraska. Complicating matters further is that possessing and growing marijuana is still a federal crime.

Though the U.S. Justice Department has taken a relaxed stance toward the legalization efforts of states like Colorado, it is still illegal to take the drug out of the state. For law enforcement in Kansas , it has been a conundrum: though the Sheriff's office has little desire to arrest people carrying legal weed out of Colorado, both federal and Kansas state law hold that the substance is illegal.

In a recent interview, Sheriff Cody Beeson of Cheyenne County, Kansas, related how accidents and routine traffic stops often produce evidence of cannabis being transported out of Colorado, an issue that is increasing law enforcement costs in his county. Often, his staff has to spend time on pot-trafficking issues, neglecting other duties. The Sheriff of Goodland, Kansas, worries that the surge in weed-smuggling arrests will deplete his budget quickly this year, since each inmate costs the county $45 for each day spent in a jail cell.

A growing black market troubles Colorado's neighbors

Neighboring states like Nebraska also worry about a burgeoning black market in Colorado weed, a situation that legalization was supposed to extinguish.

Even within the state of Colorado, it still exists, primarily due to the higher prices being charged for the legal cannabis. The only reason that the black market has suffered within the state, says a dealer interviewed by CBS4 in Colorado Springs, is because almost anyone can obtain a medical marijuana card - if they really want to.

Outside of the state, of course, things are different. The stellar quality of the weed sold in Colorado has gained a reputation, and the federally funded Rocky Mountain High-Intensity Drug Trafficking Area program has tracked the product to 40 other U.S. states.

No reprieve in sight

With the mish-mash of marijuana laws currently in force, 76% of Americans live in a state that has at least some level of legal tolerance for marijuana, and it seems like legalizing the drug at the federal level would bring instant relief to those states forced to expend taxpayers' money chasing smugglers of recreational pot. Even the director of the RMHIDTA expressed frustration with the lack of consistency in the laws regarding cannabis.

But the agonizingly slow pace of marijuana legalization seems certain to plod on, with Washington state beginning its own recreational industry this summer. Perhaps states will legalize pot as a sort of self-defense measure, finally realizing that legalization is the only sure-fire way to stop spending money fighting weed - and, like Colorado, to begin making money by embracing it.
 

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http://guardianlv.com/2014/08/cannabis-oil-cured-cancer-says-54-year-old-father/




(UK) Cannabis Oil Cured Cancer, Says 54 Year Old Father


A 54 yr. old British father-of- three, claims cannabis oil helped cure him of cancer. In 2012, Trevor Smith was diagnosed with bladder cancer and was told by doctors that he would be dead within 24 months if surgery to remove nodes on his bladder, prostate, and lymph were not removed immediately. With a concern for the quality of life after having radical surgery such as the removal of organs and surrounding tissues, he came across some information on cannabis oil on the internet while looking for alternative therapies.

Smith claims that after 10 weeks of treatment, the cancer had not metastasized, despite warning from the doctors about delaying the surgery. The doctors now state the the condition has gone into remission, and Smith, who is a manger in the oil industry, has been free of cancer for at least a year now. He says that a debt is owed to the medicinal properties of cannabis oil, and patients should be better informed of alternative therapies that exist.

Some research suggests that the active ingredients found in cannabis, known as cannabinoids, may have an effect in preventing the developing of certain types of tumors. According to studies reported by the National Cancer Institute, some anti-tumor effects from cannabinoids were observed when the study was conducted with rats and and mice, The various mechanisms for the effect include inhibition of the growth of cells, inducing of cell death, inhibition of the invasion of tumors,and tumor angiogensis, which is the development of new blood vessels that tumors need for continued growth. The research conducted with the National Institutes of Health indicate that cannabinoids appear to destroy only tumor cells without affecting non-cancerous cells, and may even offer some form of protection.

Smith had experienced excruciating pain, even though his health had improved while adopting a healthy diet and alternatives that included vitamin supplements and Essiac tea. The cancer, however continued to spread , and along with his 55 yr. old wife Carol, the couple resorted to the use of cannabis oil, which they claim has help to cure his cancer, while knowing of the risk of prison sentencing in the UK, for possessing large quantities of an illegal drug.

In the UK, there is no recognition of the use of Cannabis for medicinal purposes, and the Government has rejected calls for any type of legislation. However, clinical trials are being funded in the country by Cancer Research UK , which is an independent non-profit organisation, focused on combating cancer in the U.K. Doctors are able to prescribe the drug for treating nausea and vomiting, but possession may still carry a penalty of up to five years in prison. The Derby couple was supplied with the drug from a legal manufacturer in the U.S., and Smith says it was not a question of disregarding the law, but the bigger issue was saving his own life.

The couple, who have been married for 33 years, has written a book that documents the therapy, which includes daily doses of 60 grams of cannabis oil over a ten-week period. They say that neither of them had any prior experience with any recreational drugs, and the initial reaction was very uncomfortable.

There are continuing efforts to understand and appreciate the mechanism, by which cannabis oil works to cure cancer, as 54 yr, Harold Smith believes, but researchers believe that the active ingredient, THC and cannabinoids, actually trigger the death of some cells, and the cancerous cells become more sensitive to other therapies, which are now more effective.
 

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http://www.marketwatch.com/story/cannabis-technologies-announces-second-therapy-cti-091-2014-08-18




Cannabis Technologies Announces Second Therapy -- CTI-091


VANCOUVER, BRITISH COLUMBIA, Aug 18, 2014 (Marketwired via COMTEX) -- Cannabis Technologies Inc. (cse:CAN)(otcqb:CANLF) is pleased to announce the development of a therapy containing a proprietary mixture of cannabinoids and non-cannabis based active ingredients "CTI-091" for the relief of joint pain and swelling associated with arthritis and joint disease. Preliminary laboratory studies showed CTI-091 suppresses the human macrophage interleukin-6, a major biomarker of inflammation, indicating strong scientific evidence that cannabis extracts reverse the disease progression.

CTI-091 is designed to enhance retention and absorption of the key ingredients around the target site and designed for the relief of joint pain and swelling.

Currently the formulation is in preclinical stage of development. The company is also working to improve the delivery system to increase efficacy. We are expecting to go to initiate clinical phase 1 trials upon completion of these steps.

Craig Schneider, Cannabis Technologies President and CEO, says "We are extremely pleased to announce a second therapy in our expanding product pipeline. The pain and arthritis therapy takes our company to the next stage of development, reinforcing the proof of concept of our Cannabinoid Drug Design Platform. This platform is designed to effectively identify and fast track new drug therapies. The company plans to have numerous therapies over the next 12 months within the product pipeline focusing on other areas like metabolic diseases (Obesity & Diabetes), Orphan diseases (Huntington's & Epilepsy) as well as Cancer and Angiogenesis."

Pain & Arthritis Market

More than 46 million Americans have arthritis or a related disease, and some experts estimate the global market for arthritis drugs brings as much as $35 billion a year in profits. The many different types of drugs used to treat arthritis and its accompanying pain, includes over-the-counter and prescription-only drugs, with delivery methods of injections, infusions, patches and topical agents.

About Cannabis Technologies ("CTI")

CTI is a biopharmaceutical drug discovery and development company uniquely focused on the pharmacology and therapeutic potential of cannabinoids.

CTI is utilizing its proprietary "Cannabinoid Drug Design Platform" to identify new bioactive compounds within the marijuana plant that interact with certain gene responsible for specific diseases.

Our extensive research and intellectual properties will initially be focused on the development of several new cannabinoid based treatments for Ocular, Cancer & Angiogenesis, as well as Inflammation and Pain.

ON BEHALF OF THE BOARD

"Craig Schneider"

President and CEO
 

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http://www.telegraph.co.uk/finance/...4/How-to-turn-cannabis-into-a-legal-drug.html




(UK) How to turn cannabis into a legal drug


Dazed and confused about how a British drug maker can legally sell a drug made from cannabis in several countries around the world?

Come this way for enlightenment.

Step One: Get a scientific theory

Scientists believe that the cannabis plant contains hundreds of compounds, or cannabinoids, that hold medicinal properties. To date, around 60 of these have been identified.

GW works with several university research labs to understand the chemical make-up of each cannabinoid and from there to identify potential therapeutic applications. This research provides GW with a scientific basis to look into the therapeutic effects of a specified combination of cannabinoids in a particular ailment.

Step Two: Grow the right kind of cannabis

Plants have extremely complex chemical make-ups and cannabis is no different. No two plants contain quite the same blend of cannabinoids.

This presents GW with two challenges.

First, it must breed cannabis that has the right blend of cannabinoids for the purposes of the treatment it is looking to develop.

For example, the plants used to make Sativex, its mutiple sclerosis medicine, must contain high levels of both tetrahydrocannabinol (THC) and cannabidiol (CBD). However it needs a high-CBD, low-THC strain for its epilepsy drug Epidiolex.

GW does not use genetic modification so it creates new breeds the old-fashioned way - by crossing different types of plants.

Second, it must make sure every single bottle of medicine that rolls off the production line contains an identical cocktail of cannabinoids. This means that once it has developed a breed that contains the right blend of compounds, it must only use exact clones of this plant for future development. So once it has hit on the right breed, it will grow generation after generation of the same plant in a separate greenhouse to avoid accidental breeding with other strains.

Step Three: Refine your extract

GW has a very specific blend of cannabinoids in mind for each experimental drug it develops.

Sometimes it can achieve this by breeding alone, when the extract of a specific plant contains the target levels of cannabinoid.

But most of the time GW will want its medicine to contain just a single cannabinoid or just a small number of them. So it will breed a plant with high levels of these particular cannabinoids and then purify the resulting extract by removing the unwanted compounds.

Step Four: Test, test, test

This bit takes years.

To get regulatory approval for a particular drug, GW must gather an enormous amount of clinical data demonstrating both its safety and effectiveness in humans - and that's after it has already run tests in animals.

First, it will test the drug in a small group of patients with the target disease to make sure it does not have any harmful side effects. These trials will probably only involve tens of people.

Then it must run trials on several hundred patients to get enough proof that its medicine has a meaningful effect.

Regulators place high scientific standards on these trials. This means GW must test its drug against a placebo and neither the patient nor the doctor must know which is being used in any given case. This helps avoid bias in recording results.

Step Five: Record your medicine's fingerprint

For any given medicine, GW must prove to regulators that each batch it produces is identical.

So once it has extracted the oil from its chosen cannabis plant, it uses a powerful computer to compile a very precise chemical profile.

It puts all subsequent batches through the same process to prove that each batch of oil is identical.

Step Six: Take it to the regulators

To get permission to sell a drug in any given country, the regulator in charge must give the official nod.

Once GW has gathered enough evidence to demonstrate that its drug works, it must submit an enormous file to whichever regulator patrols the region it wants approval in. regulators. For US approval, it goes to the FDA, for EU approval, it goes to the EMA, and so on.

The regulator spends several months going through the evidence with a fine-toothed comb before deciding whether to give the medicine the final nod.
 
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