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Optimi Health Corp
Symbol OPTI
Shares Issued 87,227,566
Close 2024-01-19 C$ 0.305
Market Cap C$ 26,604,408
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Optimi gets OK to increase quantities under HC licence

2024-01-19 09:48 ET - News Release

Mr. Bill Ciprick reports

OPTIMI HEALTH SECURES AMENDMENT TO INCREASE QUANTITIES OF MDMA, MDA, AND 2C-B UNDER CONTROLLED DRUGS AND SUBSTANCES DEALER'S LICENCE

Optimi Health Corp. has been granted an amendment to its Health Canada controlled drugs and substances licence. Effectively implemented on Jan. 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA and 2CB under Subsection J.01.059(4) of Part J of the Food and Drug Regulations.

Terms of the amendment now permit the following increases:

  • N-methyl-3,4-methylenedioxyamphetamine (MDMA) -- from two kilograms to 20 kilograms;
  • 3,4-methylenedioxyamphetamine (MDA) -- from one kilogram to two kilograms;
  • 4-bromo-2,5-dimethoxybenzeneethanamine (2C-B) -- from 400 grams to four kilograms.

The obtained amendment is a crucial component of Optimi's strategy to solidify its position as an industry-leading psychedelics drug manufacturer, strategically positioning itself in anticipation of the potential approval of MDMA by the U.S. Food and Drug Administration in 2024.

Bill Ciprick, Optimi's chief executive officer, underscored the strategic importance of the amendment, stating: "This marks a pivotal achievement in Optimi's strategic licensing plan, positioning us with one of the most robust licensing portfolios globally. It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP [good manufacturing practice] MDMA and other psychedelic substances."

In its year-end annual review, the company laid out its 2024 strategic licensing plan, which includes approvals for a drug master file (DMF) and drug establishment licence (DEL). This critical documentation affirms Optimi's commitment to regulatory compliance and transparency, laying the foundation for streamlined communication with regulatory authorities and delivering high-quality APIs (active pharmaceutical ingredients) and controlled substances that meet global standards for pharmaceutical manufacturing and control.

Optimi now has Health Canada approval to manufacture the following controlled substances:

  • 2,5-dimethoxyphenethylamine;
  • 3,4-methylenedioxyamphetamine;
  • 4-bromo-2,5-dimethoxy-n-(2-methoxybenzyl)phenethylamine (25-BNBOMe)
  • 4-bromo-2,5-dimethoxybenzeneethanamine (2C-B);
  • 4-chloro-2,5-dimethoxy-n-(2methoxybenzyl)phenethylamine (25C-NBOMe);
  • 4-hydroxybutanoic acid (GHB);
  • 4-iodo-2,5-dimethoxy-n-(2-methoxybenzyl)phenethylamine (25I-NBOMe);
  • Harmaline;
  • Harmalol;
  • Ketamine;
  • Lysergic acid diethylamide (LSD);
  • Mescaline;
  • N,N-dimethyltryptamine (DMT);
  • N-methyl-3,4-methylenedioxyamphetamine;
  • Phencyclidine;
  • Psilocin;
  • Psilocybin;
  • Salvinorin A.

About Optimi Health Corp.

Optimi Health is an end-to-end drug researcher and formulator licensed by Health Canada to produce and supply, for clinical research purposes, psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA), natural GMP-grade psilocybin, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the company's goal is to be the No. 1 trusted, compassionate supplier of safe drug candidates throughout the world. Optimi's products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, B.C.

We seek Safe Harbor.

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