Activists arrested at DEA protest

Protestors of psilocybin ban arrested at DEA headquarters

At least 17 activists were arrested for protesting at the DEA headquarters. The purpose of the protest was to raise awareness about the DEA’s obstruction of access to psilocybin therapy, which should be legal for terminally ill patients through the Right to Try (RTT) laws.

“There is urgent need for the DEA to accommodate RTT and enable access (to psilocybin). This demonstration shines the bright light of public concern and outrage on this agency’s conduct,” says Kathryn Tucker, the attorney behind the litigation.

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Lawsuit against DEA for denying psilocybin access rejected

Federal Appeals Court Dismisses Cancer Patients’ Case To Use Psilocybin Under Right-To-Try Laws

A lawsuit filed by a physician and his cancer patients against the DEA for denying access to psilocybin therapy was rejected by the Court of Appeals.

The panel of judges determined that the agency is not at fault because it does not have the authority to waive the Controlled Substances Act.

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A letter to the DEA

Bipartisan Congressional Lawmakers Tell DEA To Allow Psilocybin Treatment For Terminal Patients

Representatives from seven US states (Oregon, Nebraska, Michigan, Arizona, Texas, Minnesota, and Pennsylvania) have submitted a letter urging the Drug Enforcement Administration (DEA) to allow terminally-ill patients access to psilocybin treatments. The lawmakers believe that psilocybin qualifies as an investigational drug and should therefore be accessible through Right to Try laws.

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Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics is pleased to announce that the company has been approved by the United States Drug Enforcement Agency (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds at their San Diego, California laboratory.

The company’s Schedule I DEA License was granted final approval after the DEA conducted an extensive in-person audit of Mycrodose Therapeutics’ facilities and after the FDA conducted an extensive review of the company’s in-depth research protocols for using Psilocybin, LSD, MDMA, and DMT in the development of their IP protected drug delivery technologies.

Mycrodose Therapeutics is one of a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds by the United States Drug Enforcement Agency (DEA).

“With the approval to research four Schedule I active pharmaceutics ingredients in our laboratory, we are extremely excited to marry those substances with our proprietary advanced drug delivery technologies. We are confident that our non-conventional drug delivery platforms will not only make the use of psychedelic drugs much safer but also increase the number of patients that can be treated with these powerful APIs. I’m thinking here in particular about children and the elderly. Due to the projected tight dosage control and the convenience of use, we are poised to elevate the status quo of psychedelic drug use in many medical conditions”, says Dr. Kochinke, Mycrodose Therapeutics, Chief Science Officer.

Dr. Frank Kochinke has over 30 years of experience inventing advanced drug delivery technologies and working with Schedule I compounds within the pharmaceutical-biotech industry. Having this in-house core expertise allowed Mycrodose Therapeutics to apply directly to the DEA, whereas many companies in the Psychedelic sector rely on the experience of third-party research institutions or Universities to carry out their research protocols.

Mycrodose Therapeutics laboratory in San Diego is currently in development of two (2) of their four (4) core technologies; the transdermal patch and transmucosal lozenge. The company’s IP Protected technology delivers a sustained and controlled dose of medicine into the body over time, which is believed to be safer and more effective than conventional drug delivery methods.

“We are excited to have a team with the expertise to obtain our Schedule I DEA license without needing to partner with a research institution or University. This milestone continues to validate the depth of our team, our research protocols, and our technologies,” says Chad Conner, Chief Executive Officer.

About Mycrodose Therapeutics:
Mycrodose Therapeutics (http://www.MycrodoseThera.com) is a US-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing psychedelic compounds to treat mental health and cognitive degenerative diseases. Mycrodose is one of only a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds: Psilocybin, MDMA, DMT & LSD by the United States Drug Enforcement Agency (DEA).

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom
Chief Operating Officer
Mycrodose Therapeutics
Email: mailto:Patrick@MycrodoseThera.com [Patrick@MycrodoseThera.com __title__ null]
Phone: 1-619-494-1367
Website: http://www.MycrodoseThera.com

DEA Backs White House Plan To Streamline Research On Marijuana, Psychedelics And Other Schedule I Drugs

DEA Backs White House Plan To Streamline Research On Marijuana, Psychedelics And Other Schedule I Drugs

The Drug Enforcement Administration (DEA) and National Institute On Drug Abuse (NIDA) showed support for Biden’s plan to accelerate research on cannabis and certain psychedelics. The plan would reduce the requirements to research Schedule I substances, making them more similar to the Schedule II requirements.

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DEA once again increases legal production of psychedelics

DEA Again Boosts 2022 Production Goals For Psychedelics Like Psilocybin, MDMA and DMT

DEA is once again increasing the production quotas of these psychedelic drugs for 2022: 

  • Psilocybin increased from 3,000 to 8,000 grams
  • Psilocin increased from 2,000 to 3,000 grams
  • MDMA increased from 3,200 to 8,200 grams

DMT increased from just 250 to 3,000 grams

The new limits will allow more researchers to study the drugs!

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Psilocybin production increases 11,900%

DEA Boosts Psilocybin, MDMA And DMT Production Levels Again In Final Quotas For 2021

To keep up with the growing demand for psychedelic research, the DEA is yet again increasing the legal production quotas for certain Schedule I substances!

The original proposal for psilocybin was just 50 grams, which increased to 1,500 grams in September. The final quota is now 6,000 grams – a total increase of 11,900%!

Production of both MDMA and DMT increased 6,300% from 50 grams to 3,200 grams.

 

Cybin Granted DEA Schedule I Manufacturing License

Cybin Granted DEA Schedule I Manufacturing License

The Company Also Welcomes Leah Gibson as its New Vice President of Investor Relations

TORONTO, CANADA – November 4, 2021 – Cybin Inc.(NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics TM”, today announced that the Company has been granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency (“DEA”). The DEA license is a federal requirement for any investigators who intend to study, produce, analyze or otherwise work with Schedule I controlled substances.

The DEA license is for the Company’s research lab in the Boston area. The license will allow the Company to further become a hub for innovation and drug discovery. Previously, the Company conducted much of its research and development (“R&D”) work through globally licensed research organizations in the U.S., Canada, and the U.K., and through certain in-house capabilities. With the DEA license, the Company will be able to vastly expand its internal R&D capabilities to support innovative drug discovery and delivery involving Schedule I compounds.

“We are pleased with the progression of our clinical and regulatory efforts since the Company’s formation. This new license further positions the Company as a truly integrated biopharmaceutical company that can continue to work towards progressing Psychedelics to Therapeutics,” said Doug Drysdale, Cybin’s Chief Executive Officer.

The Company is also pleased to announce the appointment of Leah Gibson to the position of Vice President of Investor Relations. Leah is a life sciences investor relations leader with more than 18 years of experience in corporate and shareholder communications, and business strategy development. She has spearheaded multiple strategic investor relations programs including an award-winning and best-in-class program responsible for driving $1.1B in institutional open-market investments over 12 months and increasing international shareholder presence. Leah has vast experience in working with small-cap and large-cap publicly traded biotechnology companies, including a $60B large-cap biotechnology company focused on creating transformative medicines for serious diseases.

As a transition with Leah Gibson becoming the new Vice President of Investor Relations, the Company also today announced that John Kanakis will step down from his Chief Business Officer position which was primarily focused on the management of investor and media relations functions. He will continue with the Company in a role to focus on M&A and business development opportunities.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally-recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the USA, UK and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended June 30, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media Contacts:

Leah Gibson

Vice President Investor Relations

Cybin Inc.

leah@cybin.com

 

Tim Regan/Scott Eckstein

KCSA Strategic Communications

cybin@kcsa.com

 

Lisa M. Wilson

In-Site Communications, Inc.

lwilson@insitecony.com

Novamind Granted DEA Licenses for Psilocybin Research

Novamind Granted DEA Licenses for Psilocybin Research

Licenses a key step in hosting contracted clinical trials for Schedule 1 controlled substances

TORONTO, ON / October 13, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine is pleased to announce it has been granted Schedule 1 licenses (the “DEA Licenses”) from the U.S. Drug Enforcement Agency (DEA) for Dr. Reid Robison, Chief Medical Officer, and Dr. Paul Thielking, Chief Scientific Officer. The DEA Licenses are required for research sites planning to host clinical trials for psilocybin, enabling principal investigators to store and administer this controlled substance.

“Obtaining the DEA Licenses is a critical step towards hosting clinical trials for psilocybin-assisted psychotherapy,” commented Dr. Robison. “We’re proud of our clinical research organization’s track record investigating innovative solutions for central nervous system conditions. This milestone reflects our expertise and enables us to continue on our mission to create breakthroughs in mental health treatment.”

Psilocybin has shown significant positive outcomes for people with major depressive disorder1 and for reducing anxiety and depression in people with life-threatening cancer.2 As of today, there are over 50 clinical studies actively examining the use of psilocybin, as listed on www.clinicaltrials.gov.

“The DEA Licenses are timely,” said Dr. Thielking, who last week launched Psychedelic Palliative Care by Novamind, a first of its kind program to support the mental health of patients and families struggling with serious illness. “We anticipate that this progress will accelerate the approval process for us to become a research site for additional psychedelic clinical studies in the future.”

To learn more about Novamind’s clinical research division, visit www.cedarclinicalresearch.com.

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

1: https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2772630
2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367557/