Discussions with Health Canada regarding Halucenex obtaining a Controlled Drugs and Dealer’s License are progressing well and the company expects the Dealer’s License could be granted imminently
Creso Pharma (ASX: CPH) (OTC: COPHF) (FRA: 1X8) provided investors with an update on the recent operational progress of its wholly-owned, Canadian psychedelics company, Halucenex Life Sciences. As previously announced, Halucenex has completed all requirements to satisfy USP 61 conditions, which provide significant validation for the use of its GMP grade psilocybin.
Halucenex has also commenced USP 62 protocols, alongside leading R&D partner Nucro-Technics. The USP 62 test evaluates a product for the presence or absence of potential pathogens. USP 62 tests are necessary for cosmetic and personal products to determine that any microorganisms that may be present in a product are not specific pathogenic microorganisms of particular concern if found in a consumer product. Once this test work is complete and if successful, it will deem the Company’s products safe for human consumption.
Test work is well progressed and once complete, the data generated will allow Halucenex to further progress its Clinical Trial Authorisation (CTA) with Health Canada. The Company remains in advanced discussions with the regulatory body regarding the status of its Controlled Drugs and Substances Dealer’s license. The Company believes receipt of the Company’s Dealer’s License is imminent, which will allow further steps to be taken towards the commencement of a phase II clinical trial into the efficacy of psilocybin when used for the treatment of Treatment-Resistant Post Traumatic Stress Disorder (PTSD).
The PTSD therapeutics market represents a large opportunity for Halucenex and Creso Pharma and is estimated to be worth upwards of USD $10.5 billion by 2025. Pending success in clinical trial initiatives and through additional, planned R&D, Creso Pharma will be well placed to capitalize and grow its market share across the sector.
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