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The Billion Dollar Psilocybin Patent Race

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Psychedelics Pending Patents: Can A Company Own Psilocybin Forever and Ever?

 

An interesting money grab is taking place in the psychedelics space as Cannabis.net first hinted at during their review of the Benzinga Psychedelics Conference in Miami.  They covered the general subject of how companies can make money in mushroooms and what is the homerun, retirement type money grab going on.  The subject is covered here in the article:

But wait, how is anyone going to get rich in psychedelics to begin with?  The big homerun pitch is in the creation of as many novel molecules as a company can create and then get a patent on them as soon as possible.  There are thousands of patents being sent in by early state psychedelic companies as part of a “molecule land grab” if you will, being that if you own the patent on XYZ novel molecule, and it later helps to reverse dementia in seniors, guess what?  You just bought yourself an island.

Smart money is setting up their companies in this manner in order to someday, fingers crossed, be bought by Big Pharma.  An IPO or sale to Big Pharma is the homerun, so having IP (intellectual property) many at experts feel is the key to a big payday down the road.  If your company has a patent on 4,000 novel molecules that need research, the odds are better one of them turns out to be medically miraculous, as opposed to a company that may have 500 novel molecule patents. These novel molecules, many with no research being done on them, are like little lottery tickets for these very small psychedelics companies. Enveric Biosciences is publicly traded and is aggressive in following this model.  Psychedelics also has an ETF, from AdvisorShares, the symbol is PSIL, for psilocybin.

 

Well, it seems that companies are trying to go for the trillion dollar home run itself, psilocybin!

 

The real crystal structures of medicinal psilocybin were revealed on December 20, 2021, thanks to ground-breaking research carried out by the Usona Institute, a 501(c)(3) non-profit medical research organization with its headquarters located in Madison, Wisconsin. This finding represents an important understanding of the innate traits of the plant’s polymorphs that had remained hidden up to this point.

 

However, this revelation has sparked a contentious debate within the psychedelics sector regarding the pursuit of synthetic psilocybin patents by Compass Pathways (NASDAQ: CMPS), a prominent player in psychedelics product development. They claim to have discovered essentially the same polymorph that the Usona research has now documented.

 

The recent study from the Usona Institute elucidated the experimental hurdles encountered in unraveling the crystallographic mystery of synthetic psilocybin, shedding light on the polymorphs, distinct crystalline structures naturally arising from synthetic psilocybin production.

 

Usona asserts that their study unequivocally demonstrates the recurrent occurrence of three psilocybin polymorphs resulting from the well-established crystallization process. These polymorphs have reportedly manifested across numerous instances in the history of psilocybin synthesis dating back to 1959.

 

In essence, the study posits that there are no groundbreaking findings to be gleaned from this research.

 

However, Compass Pathways holds a divergent viewpoint. The company claims to have pioneered polymorph A, the crystalline form of psilocybin utilized in their synthesized formulations, and is seeking to patent it. Yet, experts caution against hasty conclusions.

 

Navigating the Patent Dilemma

 

According to the Usona team of chemists and collaborating crystallographers, they have successfully deciphered crucial psilocybin crystal structures by analyzing powder X-ray diffraction (PXRD) data collected at the Advanced Photon Source synchrotron at Argonne National Laboratory.

 

During the course of Usona’s process-scale crystallographic investigation, three distinct crystalline forms of psilocybin were consistently observed: hydrate A, polymorph A, and polymorph B. While the crystal structure of hydrate A had previously been resolved using X-ray diffraction, Usona’s study introduces novel solutions for the crystal structures of the two anhydrates, polymorphs A and B, which were previously unidentified despite being part of the crystalline structure reported in the 1970s.

 

Dr. Alexander Sherwood, the lead author of the study and a medicinal chemist at Usona, emphasized that their approach involved piecing together available clues to construct a comprehensive understanding of the three psilocybin polymorphs. He stated, “The process of isolating and crystallizing pure psilocybin has been consistently replicated since its initial report in 1959, and various historical indicators pointed towards the existence of three psilocybin polymorphs resulting from this process.” Sherwood added, “The crystal structure solutions effectively amalgamated all historical evidence and data with precision and sophistication. By consolidating this information, a coherent and compelling narrative emerged regarding psilocybin crystallization.”

 

And Then An Unexpected Turn

 

The release of fresh information from a nonprofit dedicated to furthering our knowledge of psilocybin has provoked a dispute between corporations hoping to profit from new discoveries by obtaining patent protection and traditionalists who oppose psilocybin’s patenting.

 

Open Compass Pathways. COMP 360 is a synthetic psilocybin formulation made using crystalline psilocybin, created by this business. Compass Pathways received its fifth U.S. patent (U.S. Patent No. 11,180,517) from the U.S. invention and Trademark Office (USPTO) in November 2021. The invention covers crystalline psilocybin therapy approaches for treatment-resistant depression (TRD).

 

However, a petition filed on December 15 aims to challenge the patent granted on March 16, 2021. Further petitions challenging Compass’s patents are anticipated from Freedom to Operate (FTO), a non-profit organization dedicated to combating erroneous and unjustly issued patents in support of scientific advancement and education.

 

The December 15 FTO petition cited expert declarations from Dr. Sven Lidin (Dean at Lund University in Sweden) and Dr. James Kaduk (Professor of Chemistry at Illinois Tech and contributor to the Usona study). They assert that “Polymorph A” is merely a blend of known psilocybin polymorphs, rendering Compass’s patent invalid for claiming a non-existent polymorph.

 

This development raises questions about whether Compass can legitimately claim to have identified a new crystalline structure—a purported novel variant as mentioned in their patent application—for their synthetic psilocybin. Does the revelation by Usona and the contentions in the petition now nullify Compass Pathway’s patents on synthetic psilocybin?

 

Usona researchers also touched upon this matter in their study, recommending revisions to characterizations in recently granted patents that incorrectly depict crystalline psilocybin as a single-phase “isostructural variant.”

 

Simply put, the legitimacy of Compass’s patents utilizing crystalline psilocybin is up for debate—potentially rendering them invalid.

 

Yet, the clash between the Usona Institute and Compass Pathways underscores a broader issue between non-profit organizations in the psychedelics realm, such as Usona, focused on developing and enhancing therapeutic solutions for human ailments, and for-profit entities like Compass, aiming to establish control over the access and utilization of a natural substance.

 

This conflict raises pertinent questions for the psychedelics community: Who should have the authority to commercialize and regulate psilocybin? Or, perhaps more fundamentally, should such commercialization even be pursued?

 

The proliferation of patent applications has prompted the UC Berkeley Center for the Science of Psychedelics to launch a patent tracker. This initiative aims to monitor the progress of patent applications through the U.S. Patent and Trademark Office’s review process. The center highlights that a range of entities, including nonprofits, pharmaceutical firms, startups, and academic institutions, are vying to patent specific psychedelic compounds and formulations.

 

Carey Turnbull, the founder and director of FTO, articulates a nuanced perspective in a letter, stating, “No one disputes Compass’s role in manufacturing and distributing psilocybin for medical purposes, including myself. However, Compass’s efforts to monopolize psilocybin production and distribution raise concerns.” He adds, “(Compass) is seeking patents for inventions they did not create. While patents are an integral aspect of the system, the pursuit of patents that appropriate existing knowledge and then restrict its use represents a misuse of the system.”

 

Bottom Line

The clash over psilocybin patents epitomizes a broader ideological conflict within the psychedelics community, raising profound questions about ownership, commercialization, and ethical stewardship. As the debate intensifies and legal challenges unfold, it becomes increasingly clear that the future of psilocybin lies at the intersection of scientific innovation, corporate interests, and societal values. The outcome of this dispute will not only shape the landscape of psychedelic research and development but also have far-reaching implications for the accessibility and regulation of these substances. As stakeholders navigate these complex issues, it is imperative to prioritize transparency, collaboration, and the collective pursuit of knowledge for the betterment of humanity.

 

WHAT IS PSYCHEDELICS ALL ABOUT RIGHT NOW, READ ON…

BENZINGA PSYCHEDELICS

BENZINGA PSYCHEDELICS SHOW – IS THIS WEED 2.0?

 



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Foreign Investment in U.S. Cannabis: Five Key Considerations

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Cannabis investments are difficult enough when the investor is a U.S.-based person or entity. But things can get immensely more complicated when foreign investment is on the table. Today I want to highlight some of the top considerations for foreign investors and U.S. cannabis companies alike.

1. Legality could cause serious headaches

To this day, cannabis remains federally illegal. State legality has zero effect on federal law. Even the possible rescheduling to schedule III of the Controlled Substances Act (CSA) will not make cannabis federally legal. Things are clearly a mess.

In our cannabis team’s experience, a huge number of foreign investors do not appreciate the nuances between state and federal law and how it could effect them. For example, federal tax laws are unforgiving and don’t allow standard deductions for marijuana businesses. Additionally, federal illegality means that businesses will be siloed without interstate commerce, can’t get access to banking, can’t get access to basically anything for market rate, and so on.

All of these things mean that investments are simply unlikely to net big returns. Sadly to say, lots of investors end up writing off their investments. While federal legality alone isn’t the only reason that businesses, and by extension foreign investments, fail, it’s certainly a big one.

2. Cannabis investment may not be compatible with home country laws

This is actually probably more important than point 1. Cannabis is still illegal in most places in the world. There are still places where possession of cannabis can lead to the death penalty. While possession in a such a country is different from investing into the U.S., the governments in those countries may not see eye to eye, and such investments could lead to a host of different penalties. I’ve spoken with attorneys and business people from other countries who have said that foreign investment directly into a cannabis company is simply not possible.

What this can often lead to is investment into adjacent or ancillary companies in overly complicated deals. And when something is ancillary to the industry and/or a deal is overly complicated, netting a healthy return on investment is even more unlikely.

3. The cannabis industry and immigration law do not mix

Probably the first issue that comes up when looking at foreign investment is immigration and visa status. Immigration law is the province of the federal government. That means that it does not mix well with cannabis. If you’ve been in this space long enough, you’ll have heard of things like denial of naturalization petitions, denial of visas, arrests, and even lifetime bans on entry into the states. So for foreign investors who plan on relocating to the U.S. or even visiting to see the company they are investing in, there are huge risks.

4. Disclosure will likely be required

All states with legal cannabis markets require disclosure of certain people affiliated with a cannabis business. In many states, this includes investors, lenders, or people with other financial interests. Sometimes, the disclosures can be relatively benign, and in other cases much more aggressive.

For reasons expressed in points 2 and 3 above, a lot of foreign investors aren’t exactly thrilled to learn that they have to give personal data (and maybe undergo background checks) over to a state agency. This is yet another reason why foreign investments are often made into ancillary companies — to avoid disclosures. But even that isn’t always likely to fix the issue, and again, overly complicated investments into ancillary companies aren’t necessarily great.

5. Investment targets may get things wrong

Foreign investors often make a critical mistake in assuming that their targets know what they are doing. I’m not talking about operational issues — though a lot of companies clearly need help there — but about legal structures. It’s not unheard of for an investor to want to invest into a company that promises something it legally cannot do — like sell stock to a foreign investor in a state with a residency requirement. Yet things like this do happen from time to time, and once a foreign investor gives money over, it’s a lot harder to get it back.

Foreign investors who know what they are doing usually work with lawyers or other professionals experienced in their target jurisdiction, not only to diligence the target’s operations, finances, etc., but also to make sure that the fundamental aspects of the investment won’t trigger massive legal liabilities.

For some of our older posts on foreign investment in the U.S. cannabis industry, see below:



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America Can’t Defend Its Border Because Border Patrol Agents Are Smoking Too Much Weed?

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A Republican senator is pushing back against a recent policy change by U.S. Customs and Border Protection (CBP) that reduced the term of ineligibility for work due to past marijuana use from two years to three months. The senator doubts the trustworthiness of recruits who have used cannabis and believes that this move jeopardizes the safety and integrity of Border Patrol agents.

 

Senator James Lankford (R-OK) wrote to CBP Acting Commissioner Troy Miller, expressing severe concerns about the effects of this shift. He stated that the amendment blatantly contradicts the Border Patrol’s principal mission of safeguarding the country from illicit drugs.

 

Ironically, no one in the Senator’s office seemed worried about the US and Canadian border where cannabis has been recreationally legal for 7 years now.  Many Canadians have been stopped and banned for cannabis use, yet the security issue does not seem relevant at the Northern border, just the Southern.

 

While the exact timing of the CBP’s policy revision remains unclear, Senator Lankford disclosed that his office became aware of it during a briefing last month.

 

The senator alleges that CBP officers told his staff that ambiguity generated by disparities between state and federal marijuana regulations in places where cannabis has been legalized had a role in the policy shift. Senator Lankford did, however, emphasize that CBP, as a federal agency, is responsible for ensuring that federal rules governing the use of illegal substances are obeyed.

 

Additionally, the senator asserted that individuals who admit to past marijuana use often disclose involvement in other criminal activities, which he deemed unsurprising. He attributed this to the fact that irrespective of state laws, users frequently obtain marijuana from unlicensed vendors in the “gray market” due to its lower cost.

 

Furthermore, Senator Lankford alleged that licensed cannabis establishments frequently encounter corruption issues, citing reports of malpractices within his state’s medical marijuana program. He claimed that undocumented immigrants are exploited for labor and subjected to adverse conditions in these facilities.

 

Addressing worries about the health repercussions of cannabis usage, the senator cited a putative relationship between marijuana intake and diseases including schizophrenia and psychosis. Despite contradicting study findings on the subject, Senator Lankford emphasized the need for federal government screening for psychiatric disorders and illegal drug use during background checks for federal jobs.

 

In conclusion, Senator Lankford cautioned that regular marijuana use, particularly in states where it is legalized, could significantly affect the trustworthiness of Border Patrol recruits, especially considering the incidence of psychosis among heavy cannabis users.

 

Concerns Over Border Patrol Recruits’ Ties to Transnational Criminal Organizations Due to Altered Marijuana Use Review Period

 

Lankford expressed concern that shortening the period for reviewing marijuana use history raises the risk of Border Patrol recruits having financially supported transnational criminal organizations for marijuana cultivated by illegal immigrant labor. This scenario directly contradicts the Border Patrol’s mission and could lead to significant security and integrity issues among agents.

 

In his capacity as the Ranking Member of the Subcommittee on Governmental Operations and Border Management, Lankford emphasized his Subcommittee’s authority over Federal hiring and border management. He strongly objected to the policy change, fearing it would undermine the security and integrity of the Border Patrol workforce. Consequently, he urged CBP to revoke the policy and reinstate the two-year review period for marijuana use among Border Patrol recruits.

 

The senator presented eleven questions to CBP, seeking clarification by May 7 on various aspects, including the rationale behind the cannabis policy alteration, its impact on polygraph passage rates, and any other modifications to employment standards related to past marijuana use.

 

In essence, Lankford’s stance is clear: despite acknowledging CBP’s ongoing recruitment challenges and advocating for legalization to bolster border security and increase the agency’s personnel, he believes that hiring individuals who may have used cannabis three months prior, as opposed to two years ago, poses an unacceptable risk.

 

Meanwhile, CBP advised its employees and their families against using even federally legal CBD products last year. The federal legalization of hemp and its derivatives has complicated CBP’s enforcement efforts, prompting officials to seek portable marijuana analyzers to swiftly identify cannabinoid profiles and differentiate between marijuana and hemp.

 

Lankford’s opposition to the policy change is unsurprising, given his longstanding reputation as a fervent prohibitionist. For instance, last September, he spearheaded a separate letter urging the head of the Drug Enforcement Administration (DEA) to reject a recommendation to reschedule cannabis.

 

Potential Impact on Border Security and Drug Interdiction Efforts

 

Senator Lankford is concerned about more than just the short-term effects of shorter qualifying periods for recruits to the Border Patrol. He predicts a chain reaction that may make border security and drug interdiction efforts less successful. Lankford contends that CBP runs the danger of admitting people who may have engaged in criminal activity in the past, especially those connected to transnational criminal organizations (TCOs), by loosening the scrutiny on prior marijuana usage. Because TCOs frequently take advantage of gaps in border control to move narcotics, weapons, and people across international borders, such links directly endanger national security.

 

Furthermore, Lankford questions the reliability of background checks and polygraph tests in identifying individuals with ties to criminal organizations, particularly given the evolving nature of drug-related crimes. The shortened review period may not provide sufficient time to uncover deeper associations or patterns of behavior indicative of criminal involvement. This, in turn, could lead to the infiltration of Border Patrol ranks by individuals sympathetic to or actively engaged in illicit activities, compromising the integrity of the agency and its mission to safeguard the nation’s borders.

 

Lankford’s worries about the wider social effects of permissive marijuana laws among law enforcement agencies go beyond the direct security ramifications. He argues that CBP’s decision may undermine attempts to curb drug misuse and related criminal activity by sending a message of tolerance toward drug use. It also calls into doubt the coherence of federal drug enforcement initiatives, particularly given disparate state legalization policies for marijuana. Lankford highlights the necessity of a unified strategy for border security and drug control, one that respects federal authority while taking into account the intricacies of changing state laws.

 

Bottom Line

 

Senator James Lankford’s staunch opposition to the recent policy change by U.S. Customs and Border Protection, which shortened the term of ineligibility for Border Patrol recruits due to past marijuana use, underscores concerns about potential risks to national security and the integrity of law enforcement agencies. His apprehensions regarding the infiltration of criminal elements into the Border Patrol workforce, coupled with doubts about the efficacy of screening procedures, highlight the broader implications of drug policy shifts within federal agencies. Lankford’s stance emphasizes the importance of maintaining stringent standards in border security efforts while navigating the complex landscape of state and federal marijuana regulations.

 

US BORDERS AND CANNABIS, READ ON…

BORDER PATROL ON WEED

BORDER  PATROL ON CANNABIS USEAGE, DON’T ASK, DON’T TELL!



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Can Florida Pull 60% of the Votes Needed on Election Night to Pass Legal Weed?

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In a blow to Gov. Ron DeSantis and other Florida conservatives opposed to the measure, the state’s Supreme Court on Monday approved a recreational marijuana constitutional amendment for the November 2024 statewide ballot.

 

The proposal, known as Amendment 3, will legalize the “non-medical personal use of marijuana products and marijuana accessories by an adult” 21 or older if approved by 60% or more of statewide voters. It would take effect six months after the election.

 

The cannabis industry may have a secret “ace card” up their sleeve if Ohio is any indication off liberal voter turnout.  You may remember that Ohio voted on cannabis legalization and abortion rights on the same ballot and voting night last year.  This dual liberal ballot caused a swell or women and liberals to hit the voting booths, passing both measures in the same night.  Florida finds itself in the same situation this November, with abortion rights on the same ballot.  A “two birds, one stone” voting night may happen again as more liberals and women come out to vote.

 

In 2021, the court rejected two proposed constitutional amendments for recreational marijuana. But this time five justices ruled favorably on the measure with only two opposing.

 

The amendment was the subject of a multi-million-dollar campaign, spearheaded by Smart & Safe Florida, a group that’s collected more than $40 million in recent years. Two dozen states have already legalized recreational weed.

 

The Florida amendment would allow non-medical marijuana possession of up to 3 ounces, with no more than 5 grams in concentrated form.

 

To get a measure on the Florida ballot, supporters must first get 891,523 signatures from residents. The Supreme Court then must decide whether the amendment language sticks to a single subject and isn’t misleading, which can be a difficult threshold to overcome.

 

But, for the majority of justices, it met that bar.

 

In light of those limited considerations, we approve the proposed amendment for placement on the ballot,” Justice Jamie Grosshans, appointed by Gov. Ron DeSantis, in the majority opinion.

 

The state Supreme Court Monday also effectively upheld a six-week abortion ban but also OK’d a ballot measure that would guarantee access to abortion, even further raising the stakes of an already pivotal presidential election.

 

Florida’s Attorney General Against Legalization of Recreational Cannabis

 

Ashley Moody, the attorney general of Florida, expressed her disapproval of the recreational marijuana ballot issue, claiming it was deceptive and did not satisfy the required requirements.

 

Additionally, Moody’s chastised the proposal for supposedly benefiting Trulieve, the biggest medicinal marijuana provider in the state and the main source of money for Smart & Safe Florida. Kim Rivers, the CEO of Trulieve, praised the court’s ruling and said she was looking forward to helping the campaign move closer to the autumn ballot.

 

The legalization of medical marijuana in Florida stemmed from a 2016 ballot measure approved by over 71% of voters. Previous polls have indicated broad support among Floridians for the 2024 recreational marijuana measure.

 

While Governor DeSantis, who has appointed five of the court’s seven justices, had anticipated the court’s approval of the recreational marijuana measure, he recently expressed concerns about its potential impact. Specifically, he mentioned worries about the odor and the lack of restrictions on where and when marijuana could be consumed, including near schools. He criticized the broad language of the amendment, stating it was the most extensive he had encountered.

 

Justice Meredith Sasso, appointed by DeSantis and one of the dissenting voices, believed the amendment misled voters, citing its language regarding the “allowance” of recreational marijuana.

 

Moody argued in court filings that describing the amendment as “allowing” marijuana use is misleading, as marijuana remains illegal federally, despite its legality in over 20 other states. However, Justice Grosshans, writing for the majority, found the amendment’s summary not misleading, noting the court’s prior rulings on medical marijuana and its jurisdiction over state, not federal, law.

 

Potential Implications for Florida’s Cannabis Industry

 

There has been much conjecture on the significant consequences that Amendment 3’s passage by the Florida Supreme Court may have for the state’s rapidly expanding cannabis sector. Leading companies in the field, including Florida’s well-known medical marijuana supplier Trulieve, are positioned to profit from the growing market as recreational marijuana use gets closer to approval. With the potential to solidify its position as a leading participant in the medical and recreational cannabis sectors, Trulieve’s significant financial support of Smart & Safe Florida’s campaign highlights the company’s strategic interest in the amendment’s successful passage.

 

However, alongside established players like Trulieve, the legalization of recreational marijuana is expected to spur increased competition within Florida’s cannabis market. As the state opens its doors to non-medical cannabis use, new entrants are likely to emerge, seeking to seize a slice of the lucrative market pie. This influx of competition could lead to innovations in product offerings, retail experiences, and branding strategies as companies vie for consumer attention and loyalty in an increasingly crowded marketplace.

 

Furthermore, Amendment 3’s adoption is likely to change Florida’s cannabis laws about retail, wholesale, and growing. The elements of the amendment, such as possession limitations and regulatory frameworks, will be crucial in determining the operational parameters that enterprises in the state’s cannabis market must adhere to. Stakeholders in the sector are keeping a close eye on changes as politicians and regulatory bodies strive to create rules for compliance and enforcement. This is so they can efficiently manage the constantly changing regulatory landscape.

 

Political Ramifications and Public Opinion on Recreational Marijuana

 

The approval of Amendment 3 by the Florida Supreme Court not only carries significant implications for the state’s cannabis industry but also holds substantial political ramifications. Governor Ron DeSantis, who has appointed the majority of the justices on the court, had previously expressed mixed sentiments regarding the legalization of recreational marijuana. While anticipating the court’s approval, DeSantis recently voiced concerns about potential societal impacts, including odor concerns and the absence of stringent consumption restrictions, especially in proximity to educational institutions.

 

In addition to DeSantis’s stance, the passage of Amendment 3 amplifies the ongoing discourse surrounding recreational marijuana at both the state and national levels. Florida’s Attorney General, Ashley Moody, echoed concerns about the amendment’s language and its potential to mislead voters. The debate surrounding the amendment reflects broader discussions on the legalization of cannabis across the United States, with advocates emphasizing social equity, criminal justice reform, and economic opportunities, while opponents highlight public health and safety concerns.

 

The public’s perception of marijuana use for recreational purposes in Florida seems to be changing despite differing opinions. Voters overwhelmingly supported the legalization of medical marijuana in 2016, demonstrating the increasing acceptability of cannabis use for therapeutic purposes. Recent polling indicates a similar trend in support of legalizing cannabis for recreational use, reflecting Floridians’ changing views on the drug. The result of the Amendment 3 vote will not only influence Florida’s cannabis industry but also act as a gauge for larger social views toward marijuana legalization in the US as the state prepares for the November 2024 election.

 

Bottom Line

 

The approval of Amendment 3 by the Florida Supreme Court marks a significant milestone in the state’s journey towards the potential legalization of recreational marijuana. Despite opposition from Governor Ron DeSantis and other conservatives, the amendment’s passage signals a shift in public opinion and could have far-reaching consequences for Florida’s cannabis industry, political landscape, and societal norms. As stakeholders navigate the evolving regulatory environment and prepare for the upcoming ballot in November 2024, all eyes will be on the outcome of the vote and its impact on the future of marijuana policy in the Sunshine State.

 

ABORTION AND WEED TOGETHER, READ ON…

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OHIO HAD ABORTION AND WEED ON THE SAME BALLOT?



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