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).
“There is a significant backlog on current test work and Halucenex has managed to traverse this and achieve very pleasing results around its USP 61 requirements, with initial data indicating a positive outcome for our USP 62 testing. The work that has gone into these two testing phases should not be underestimated. Both datasets will provide significant validation of our psilocybin and also indicate that it is safe for human consumption, prior to the commencement of our planned phase II clinical trial. We look forward to the receipt of these results in the coming weeks, as well as the outcome and award of our Dealer’s License from Health Canada. Discussions with the regulatory body have progressed well and all questions to date have been satisfied,” commented Halucenex Founder & CEO Bill Fleming.
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.
“Recent work undertaken by Halucenex has well-positioned the Company within the industry. Given the bottleneck of supply around psilocybin and our supply, we are positioned to capitalise as a first mover in the PTSD therapeutics sector. We anticipate the receipt of the Dealer’s License from Health Canada shortly. This is expected to unlock significant value for our shareholders and allow the Company to further progress its growth strategy. As the Company embarks on its proposed merger with Red Light Holland, additional synergies and benefits continue to materialise. Following completion of the merger, the combined company’s North American presence will provide a favourable operating jurisdiction to pursue joint venture and licencing agreements with large pharmaceutical companies and other potential industry partners. We look forward to updating shareholders on results from the USP 62 results and other regulatory developments over the coming weeks,” stated Creso Pharma’s Non-executive Chairman Adam Blumenthal.
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Creso Pharma is a paid client of The Cannabis Investor. The Cannabis Investor does not hold a position in CPH.
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