Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) Ltd. has revealed that on Tuesday, November 30, 2021, the company and KGK Science, the firm’s contract research organization (CRO), presented Psyched's proprietary extract of the Amanita Muscaria mushroom, AME-1, to representatives of Health Canada in a pre-submission meeting.
This came close on the heels of Health Canada's decision on November 3, 2021, to add the 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," CEO Jeff Stevens said in a statement. "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 Consumer packaged goods (CPG) 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. The meetings essentially familiarize assessment staff with the proposed application prior to its arrival and provide a forum to discuss the evidence to facilitate its assessment.
Psyched Wellness , a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, said the meetings also establish which studies or scientific evidence may be relied on to support the safety and/or efficacy of the NHP and discuss the adequacy and appropriateness of controls.
The company pointed out that a pre-submission meeting doesn’t entail a full assessment by NNHPD of the evidence presented and, as such, the outcome doesn’t constitute a regulatory decision by NNHPD, “nor will a regulatory decision be issued.”
Psyched is developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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