Author: Debra Borchardt

Debra Borchardt is the Co-Founder, and Executive Editor of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Master's degree in Business Journalism from New York University.

Recent Stories by Debra Borchardt
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Debra BorchardtDecember 15, 20235min00

It’s one piece of the cannabis industry that gets left out of the 280E conversation and this is the marketing side of the business. Since companies can’t deduct marketing expenses, when it’s time to tighten the belt, that’s the first place the cuts happen.

Public relations, advertising, sponsoring events and the creatives who make all the artwork happen have been affected by being subject to budget cutting. Now though, cannabis marketing companies could be big beneficiaries of change to the 280E tax provision.

While most of the focus has been centered on the effects on standard cannabis companies, those on the marketing side also stand to win.

Tax Change is in the Air

Since cannabis is federally illegal, cannabis companies have not been able to take standard business deductions. If the federal government reschedules the plant from Schedule 1 to Schedule 3, that would immediately change that dynamic.

Aaron Grey of Alliance Global Partners said during a presentation at the Benzinga conference in Chicago earlier this year that it typically takes 110 days after the Department of Health and Human Services (HHS) makes a recommendation to another agency – in this case the Drug Enforcement Agency – for a ruling. And once the DEA makes a ruling, it goes up for public comment.

This comment period lasts for 37 days on average, but Grey conservatively guessed it would be open for 60 days for cannabis. Then he expects an additional 203 days for a final ruling. That would place the decision sometime in the summer of 2024.

If all of this goes accordingly, companies could consider all appropriate expenses starting with the 2024 tax year.

How Does Marketing Win?

Most mainstream businesses spend as much as 9% of their budgets on marketing, according to Gartner. That number has fallen steadily from 12% back in 2016, settling at 9.5% in 2022 and 9.1% in 2023.

The Cannabis Marketing Association estimates that cannabis industry marketing budgets are much lower, coming in at roughly 0.5%-1.5% of total revenue.

“While CMA’s data and Gartner’s data are not a perfect apples-to-apples comparison, it’s still worth noting a significant gap,” Lisa Buffo, CEO and founder of the CMA, said.

If 280E is changed, Buffo said marketing companies could be beneficiaries of increased spending.

“Increased budgets for cannabis marketing will have a ripple effect. Service providers will be able to charge more (agency retainers in cannabis are far below the norm), a true omnichannel strategy could be possible, and real dollars could be spent on ad campaigns,” she said. “Marketers don’t want to be caught flat-footed when these changes happen, so we are trying to let the communications community know about this possible milestone now.”

Possible Changes

This year was certainly a challenge for many in the cannabis industry, but the marketing side took it on the chin. Budgets for public relations were slashed, and sponsorships for events disappeared.

While cannabis companies are limited as to where they can advertise, the available spaces were also devoid of ads over the past year. An increase in these budgets would also help news outlets, marketing agencies, and event producers.


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Debra BorchardtDecember 14, 20233min00

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). MindMed said that its trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4.

MM-120 was administered as a single-dose in a monitored clinical setting with no additional therapeutic intervention. The trial enrolled 198 participants who were randomized to receive a single administration of MM-120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). While it is only four weeks of results, the response is seen as a very solid result.

“We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention. These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We look forward to sharing additional study results in the coming months – including topline 12-week results in the first quarter of 2024 – and working closely with FDA as we finalize the Phase 3 development program for MM-120 in GAD.”

Around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation.

Looking ahead, MindMed said it expects that the results of this study will support the advancement of MM-120 into Phase 3 clinical development for GAD. The company also said it plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate Phase 3 clinical trials in the second half of 2024.


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Debra BorchardtDecember 14, 20234min00

A Seattle doctor is not giving up when it comes to the rescheduling of psilocybin. While the focus on rescheduling cannabis is talked about constantly, psilocybin also faces the same dilemma of being a schedule one drug. Law360 reported that Seattle physician Dr. Sunil Aggarwal filed a petition on Dec. 11, nearly two months after a circuit panel remanded his request to change psilocybin’s status back to the DEA and ordered the agency to clarify why it believes the drug should remain a Schedule I substance.

Dr. Aggarwal is requesting a rehearing stating “The Order did not address Petitioners’ argument that 21 U.S.C. § 811(b) requires a referral to the Food and Drug Administration (“FDA”) for scientific and medical evaluation and scheduling recommendation, and instead ordered a remand to the Drug Enforcement Agency (“DEA”).  This omission has both legal and practical ramifications for the Petitioners, and Petitioners request that the panel correct this legal error.”

Backstory

Aggarwal and his clinic, the Advanced Integrative Medical Science Institute (AIMS) filed the original petition with the DEA in February 2022. They argued that there was several pieces of evidence from clinical trials showing psilocybin’s efficacy in treating depression for patients in end-of-life care and urging the agency to move psilocybin to the less restrictive Schedule II category.

However, the agency rejected the petition with a two-paragraph denial letter in September 2022, asserting that since the FDA had not yet approved a psilocybin-based treatment, there was no basis for moving the drug into Schedule II.

Aggarwal pushed back saying that the DEA had not considered the evidence placed in front of it and had neglected its responsibility to consult the U.S. Department of Health and Human Services for a scientific and medical analysis of psilocybin’s potential uses and benefits. The petition went on to say that the failure to explicitly order the DEA to refer the rescheduling request to the FDA was out of step with precedential case law and public policy.

Furthermore, the petition noted that the FDA’s findings on scientific and medical matters bind the DEA, and if the Department of Health and Human Services (“HHS”) recommends that the DEA not subject a substance to control, the DEA “shall not control the drug or substance.” Only after the FDA’s binding, expert views on scientific and medical considerations are rendered may the DEA assess whether “substantial evidence” exists to warrant initiating a formal rulemaking process.

Finally, the petition summed it up stating:

If agencies could simply procure naked remands (as the Court ordered here) in response to substantive petitions, such a precedent would embolden agencies to avoid making decisions on the merits. In other words, such a precedent would incentivize agencies to say less, not more, in initial decisions, multiplying judicial workload and delaying decisions on the merits. For this additional reason, the Court should have ordered a referral to the FDA, rather than a remand to DEA.

 

1776000-1776421-aims 12.11.23 rehearing petition


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Debra BorchardtDecember 12, 20234min00

The Administrator of the Drug Enforcement Administration (DEA) has issued a temporary order to schedule six synthetic cannabinoids in schedule I under the Controlled Substances Act. The DEA said the action was based on a finding by the Administrator that the placement of these six substances in schedule I was necessary to avoid imminent hazard to public safety. The temporary order begins today and is effective until December 12, 2025.

The products are sold in gas stations, convenience stores, and smoke shops. They are sold as herbal incense and promoted as a legal alternative to cannabis.

The cannabinoids are:

•Methyl 3,3-dimethyl-2-(1-(pent-4- en-1-yl)-1H-indazole-3- carboxamido)butanoate (Other name: MDMB–4en–PINACA)

•Methyl 2-[[1-(4-fluorobutyl)indole- 3-carbonyl]amino]-3,3-dimethyl- butanoate (Other names: 4F–MDMB– BUTICA; 4F–MDMB–BICA)

•N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-(pent-4-en-1-yl)-1H- indazole-3-carboxamide (Other name: ADB–4en–PINACA)

• 5-Pentyl-2-(2-phenylpropan-2- yl)pyrido[4,3-b]indol-1-one (Other name: CUMYL–PEGACLONE; SGT– 151)

• Ethyl 2-[[1-(5-fluoropentyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate (Other names: 5F–EDMB–PICA; 5F– EDMB–2201

•Methyl 2-(1-(4-fluorobenzyl)-1H- indole-3-carboxamido)-3-methyl butanoate (Other name: MMB–FUBICA).

Synthetic Cannabinoids

The notice described synthetic cannabinoids as substances that are synthesized in laboratories that mimic delta-9- tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis. The DEA said that from 2009, abuse of SCs has escalated in the United States noting recent hospital reports, and said the products are negatively impacting communities. They also state that there are no medical uses for these products.

The DEA said that emergency room situations involving these compounds have included seizures, sudden collapse, involuntary muscle spasms, jerking movements, catatonia, and increased violence.

Multiple deaths have been reported involving MDMB- 4en-PINACA, 4F-MDMB-BUTICA, and CUMYL-PEGACLONE. In addition, all six SCs have been seized by law enforcement in the United States. Based on the pharmacological similarities between MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL- PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA and other schedule I SCs, these six SCs are likely to produce signs of addiction and withdrawal.

These products typically come from China in bulk powder form and are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. The producers then spray or mix the SCs with plant material for consumers to smoke with a pipe or rolled into a joint.

Next Steps

The new order states that if sellers don’t have a license to sell these Schedule 1 drugs, they need to surrender these products. If this order is extended or made permanent, the DEA said it will publish a document in the Federal Register.


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