full mushrooms, pieces of mushrooms on a scale and a pill case with capsules on a grey surface

The investigation of psychedelic drugs for their medical benefits is attracting investors. How does the leading US drug agency feel?

The development of the psychedelics industry depends on myriad factors, but one of the most critical is its relationship with a principal medical authority.

The US Food and Drug Administration (FDA) is the leading authority for drug approvals in the US. This federal body determines whether medical products will ultimately reach the hands of patients.

The FDA reviews the clinical data created by established medical studies evaluating the feasibility of drug compounds or products as treatments for specific ailments.


As a federal agency, the FDA has to adhere to federal policy for drugs in the US. The country's national drug-scheduling system provides data on all kinds of drugs and the regulations they must follow.

Several psychedelic compounds currently find themselves in the Schedule I category, which receives the heaviest scrutiny in the eyes of federal authorities. Cannabis is also listed in this segment.

If this is the case, then why are companies in the psychedelic drug development space pursuing clinical studies and looking for FDA approval? Interestingly, despite the legal status of these drugs, the FDA isn't so closed off that it won't examine their potential.

During the first Prohibition Partners LIVE online event, Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), told the audience he sees the FDA as an engaged partner in conversations surrounding the construction of clinical trials with psychedelic agents.

Doblin added that he perceives the FDA as a regulatory agency willing to put science over politics when it comes to the medical benefits of psychedelics. MAPS is investigating the use of MDMA as a method of psychotherapy for patients with post-traumatic stress disorder.

In 2017, this psychedelics-based method was granted "breakthrough therapy" designation by the FDA in a move that represented a change in the drug authority's perspective.

In October 2021, Doblin said MAPS expects to finish its second Phase 3 trial of MDMA in October 2022.

MAPS is a non-profit organization that is not looking to change its status anytime soon. While the group does take donations, investors looking to play the market are interested largely in public companies.

In late 2020, the psychedelics investment market saw excitement when Compass Pathways (NASDAQ:CMPS) listed directly onto a senior US stock exchange.

Similar to MAPS' method, the work done by Compass Pathways has also received support from the FDA. In 2018, the company confirmed the receipt of "breakthrough therapy" designation from the FDA for its study of treatment-resistant depression (TRD) using psilocybin. In November 2021, Compass Pathways reported positive topline data from a completed Phase IIb clinical trial of psilocybin therapy for TRD. The company also announced that it is beginning a Phase II psilocybin therapy trial for post-traumatic stress disorder.

Significance of changing mentality on psychedelics

A report by Psychedelic Support highlights the fact that the FDA and National Institutes of Health have commented on the medical benefits associated with psychedelics-based treatments.

"The message was clear. The FDA will evaluate risk-benefit profile of psychedelic substances in the same way as other investigational drugs," the report indicates.

According to the report, the agency's requirements for clinical trial designs highlight the following specifications:

  • How psychedelics work in a particular setting.
  • Timing of administration.
  • Structured approach or will multiple approaches work?
  • How fast does symptom reduction occur and how long are symptoms decreased?
  • Do people relapse, and if so can the drug retrieve them from relapse?

Investor takeaway

From the information currently available, it's clear that one of the biggest drug authorities in the world appears to be slowly but surely increasing its support of psychedelics.

What's more, the medical indications show a promising market that is already garnering support among investors. The psychedelics space looks set to continue developing as more companies come to market.

Don't forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

Featured
Seelos Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement whereby it acquired a worldwide license from iX Biopharma Ltd for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, ...

- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China Taiwan Macau and Hong Kong ) from iX Biopharma Ltd (iX Biopharma) for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.

read more Show less
Seelos Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the placement of a $22.0 million senior secured convertible note and shares of Seelos common stock to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in ...

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the placement of a $22.0 million senior secured convertible note (the "Note") and shares of Seelos common stock (the "Closing Shares") to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in Seelos. Seelos will receive $20.0 million in gross proceeds.

read more Show less
Hollister Biosciences Inc. today announced results of its 2021 Annual General and Special Shareholder Meeting held on November 22, 2021 . All of the matters put forward before the Company's shareholders for consideration and approval, as listed in the management information circular of the Company dated October 18, 2021 were approved by the requisite majority of votes cast at the Meeting. This includes the election ...

Hollister Biosciences Inc. (CSE: HOLL) (OTC: HSTRF) (FRANKFURT: HOB) (the " Company " or " Hollister Biosciences ") today announced results of its 2021 Annual General and Special Shareholder Meeting (the " Meeting ") held on November 22, 2021 .

read more Show less
text saying "top stories this week"

Catch up and get informed with this week's content highlights from Charlotte McLeod, our editorial director.

Top Stories This Week: Powell Gets Fed Nomination, Using Gold in a Market Correction youtu.be

We're back after a break last week with quite a bit to cover in the gold space.

After running up past the US$1,860 per ounce mark midway through November, the yellow metal has taken a tumble. At the time of this writing on Friday (November 26) afternoon, it was sitting just under US$1,790.

Gold's losses this week have been attributed to elements like a stronger US dollar and better Treasury yields, although Jerome Powell's US Federal Reserve chair renomination has pulled other factors into play — some market watchers believe he may move to taper and raise interest rates faster than anticipated.


If the Fed follows its previously laid out timeline for tapering, it will wrap up in mid-2022; the central bank has said it won't raise rates until after that. It has also emphasized that its roadmap may change if necessary.

Looking at the larger picture for gold, I heard recently from Nick Barisheff of BMG Group, who believes the stock market is due for a major correction.

"The market is due for a major correction. What will cause it and when it will happen is anybody's guess — it could be tomorrow, it could be six months from now" — Nick Barisheff, BMG Group

It's impossible to know when this correction will happen, but Nick emphasized the importance of acting before it's too late. He pointed out that investors are typically slow to get out of the market once a crash actually begins — they wait for a turnaround, and by the time it's clear there won't be one, they've experienced big losses.

In his opinion, the solution is to get out of the stock market early and transfer money into gold.

Here's how Nick explained it:

"Instead of taking your money off the table and going into cash … you go to gold (because cash is devaluing daily). Gold will at least hold its own and probably appreciate … so by sitting it out in gold you can wait until the market finishes correcting and then buy back in" — Nick Barisheff, BMG Group

With gold's future in mind, we asked our Twitter followers this week what price they think the metal will be at the end of 2021. By the time the poll closed, most respondents had voted for the US$1,800 to US$1,900 range.

We'll be asking another question on Twitter next week, so make sure to follow us @INN_Resource or follow me @Charlotte_McL to share your thoughts.

Finally, in the cannabis space, INN's Bryan Mc Govern spoke with Dan Ahrens of AdvisorShares to get his thoughts on 2021 trends and what's ahead in 2022.

Dan was candid, and said if he had to choose one word to describe the cannabis market in 2021, it would be "painful." Like many others, he's been disappointed in the industry's performance — while positivity initially ran high due to excitement about potential federal changes in the US, ultimately progress has been slow.

"Cannabis started with a big run-up in January and February ... and things dragged from there" — Dan Ahrens, AdvisorShares

Still, Dan has hope for 2022 and said it will be a "huge year" for cannabis. He believes US reforms will come sooner rather than later, and in his opinion those widely anticipated changes will bring a wave of M&A activity.

Specifically, he expects to see alcohol, tobacco and other consumer packaged goods companies making deals with cannabis players, not just cannabis entities doing transactions with each other.

"Those big alcohol companies, tobacco companies, other consumer packaged goods product companies — they're waiting. They're waiting on the US" — Dan Ahrens, AdvisorShares

Want more YouTube content? Check out our YouTube playlist At Home With INN, which features interviews with experts in the resource space. If there's someone you'd like to see us interview, please send an email to cmcleod@investingnews.com.

And don't forget to follow us @INN_Resource for real-time updates!

Securities Disclosure: I, Charlotte McLeod, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

cannabis plant layered with German flag graphic
Dmytro Tyshchenko / Shutterstock

Catch up on some of the biggest news of the week for the cannabis investment world.

Three political parties have formed a coalition in Germany, leading to a new government, and it has promised cannabis reform in the European nation.

Meanwhile, a popular cannabis retailer confirmed consumers will now find its products available for delivery on the Uber Eats mobile application in Ontario.

Keep reading to find out more cannabis highlights from the past five days.


Coalition of parties promises forward-looking cannabis policy

Germany, a country with comprehensive and elaborate medicinal rules for cannabis, is in a time of transition as a new government is set to begin to take over after 16 years of Angela Merkel.

Olaf Scholz, the proposed next chancellor of Germany, leads a three party coalition that will become the country's governing body. As part of its promises, talk of adult-use cannabis regulation has now gained even more momentum. A report from MJBizDaily quotes a German policy document that shows the coalition's stance:

"We are introducing the controlled distribution of cannabis to adults for consumption purposes in licensed shops. This controls the quality, prevents the transfer of contaminated substances and guarantees the protection of minors."

However, despite the promise and excitement, it remains to be seen how these ideas will be applied since no formal regulations have been drafted or approved yet.

Canadian cannabis retailer partners with popular delivery app

Tokyo Smoke, a cannabis retail operator in Canada owned by Canopy Growth (NASDAQ:CGC,TSX:WEED), announced a collaboration agreement with Uber Canada (NYSE:UBER) whereby cannabis consumers will be able to use the Uber Eats app to order products before they visit stores.

While the app won't let consumers get cannabis delivered to them, this new method opens the doors to more dynamic ways of buying cannabis.

"As a market leader in innovation and a platform used by so many Canadians, we believe this is the ideal next offering that can be done safely and conveniently on the Uber Eats app," Mark Hillard, vice president of operations with Tokyo Smoke, said in a press release.

A report from the Canadian Press indicates Ontario is considering allowing dispensaries to have delivery and pickup options made available to consumers permanently. The province allowed some of these purchasing options at the outset of the COVID-19 pandemic, but then removed them.

Lola Kassim, general manager of Uber Eats Canada, said this new end-to-end experience will provide consumers with responsible access to legal cannabis products.

Cannabis company news

  • Organigram Holdings (NASDAQ:OGI,TSX:OGI) issued financial results for its Q4 2021 period. In its report, the company notes a net loss of C$26 million despite a 22 percent uptick in net revenue to C$24.9 million. Beena Goldenberg, the newly appointed CEO of the firm, is encouraged by the market share position earned by the company, which said it became the fourth biggest producer in Canada during the reporting period.
  • Halo Collective (NEO:HALO,OTCQB:HCANF) confirmed the decision for Akanda, its spinoff company focused on international cannabis opportunities, to begin trading on a US exchange. "The number of shares to be offered and the price range for the proposed offering have not yet been determined," the company told investors in a press release.
  • High Tide (NASDAQ:HITI,TSXV:HITI) announced the acquisition of 80 percent of NuLeaf Naturals, a CBD product wellness developer, for an estimated US$31.24 million. The deal includes a three year option clause for High Tide to complete a total acquisition. "As international markets open up and as export regulations evolve, NuLeaf's cGMP-certified facility positions us to take advantage of the global CBD business opportunity," Raj Grover, president and CEO of High Tide, said.
  • Humble & Fume (CSE:HMBL,OTC Pink:HUMBF) released the financial report for its first 2022 fiscal quarter to shareholders and the market. "As the legal cannabis market in North America continues to mature, Humble remains agile and focused on providing a leading solution for brands to scale quickly and retailers to focus on their customers," Joel Toguri, CEO of Humble, said.

Don't forget to follow us @INN_Cannabis for real-time updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

MARKETS

Markets
TSX21125.90-487.28
TSXV944.05-31.53
DOW34899.34-905.04
S&P 5004594.62-106.84
NASD15491.66-353.57
ASX7279.30-128.00

COMMODITIES

Commodities
Gold1792.60+0.99
Silver23.13+0.02
Copper4.29-0.18
Palladium1751.49+10.50
Platinum955.50+2.50
Oil68.17-10.22
Heating Oil2.09-0.29
Natural Gas5.49+0.43

DOWNLOAD FREE REPORTS