Psyched Wellness Presents AME-1 to Health Canada in Pre-Submission Meeting
Toronto, Ontario, December 1, 2021 – Psyched Wellness Ltd. (CSE:PSYC, OTCQB:PSYCF, FRANKFURT:5U9) (the “Company” or “Psyched”) a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that on November 30, 2021, representatives from the Company and KGK Science, the Company’s contract research organization (CRO), presented AME-1, Psyched’s proprietary extract of the Amanita Muscaria mushroom, AME-1, to representatives of Health Canada in a pre-submission meeting.
This follows Health Canada’s approval announced on November 3, 2021 to add Amanita Muscaria mushroom to the Natural Health Products Ingredients Database (NHPID) of Canada.
“Yesterday’s pre-submission meeting was the next important step in positioning the Company to be able to file an application with Health Canada for AME-1 as a Natural Health Product in 2022,” said Jeff Stevens, CEO of Psyched Wellness. “The meeting was very encouraging, and we look forward to incorporating Health Canada’s comments and suggestions into our plans to bring our Amanita-based CPG products to market next year.”
The purpose of a pre-submission meeting is to discuss the evidence required in support of a Class III Product License Application (PLA) or to clarify the type of applications required. Such meetings will:
- familiarize assessment staff with the proposed application prior to its arrival and provide a forum to discuss the evidence in order to facilitate its assessment;
- establish which studies or scientific evidence the applicant is relying on to support the safety and/or efficacy of the NHP and discuss the adequacy and appropriateness of controls;
- provide an opportunity for the applicant to discuss details of the application with Natural and Non-prescription Health Products Directorate (NNHPD) and obtain feedback regarding any areas of concern based on current experience and regulatory requirements; and
- provide NNHPD an opportunity to re-align resources, if necessary, to accommodate the arrival of the application.
Pre-submission meetings do not entail a full assessment by NNHPD of the evidence presented and, as such, the outcome does not constitute a regulatory decision by NNHPD, nor will a regulatory decision be issued.