Further details were released by Pure Extracts (CSE: PULL) this morning in relation to its study on the formulation and manufacturing of psilocybin-based active treatments for oral tablets, capsules and nasal gel. The company has now released the timetable as well as outlined the milestones for the study, which is expected to result in an investigational product.
News of the study was previously released by the company, with research to be conducted by company advisor Dr Alexander MacGregor at the Toronto Institute of Pharmaceutical Technology. The study itself is to focus on testing the rapid onset of psilocybin dosage forms that can be used for future efficacy trials, by both Pure and its customers.
It appears the entire product chain is to be included in the study, from formulating and manufacturing, to packaging and labelling. Also included is conformity and stability testing. Based on a 250-day timeline, the company has outlined the following key milestones:
- Sourcing and procurement of medicinal ingredients, excipients & packaging materials
- Raw Material Testing
- Formulation and Manufacturing Process Development, Stability Testing
- Clinical Batch Manufacturing
- Quality Control Release Testing
- Shipping of Clinical Batches to CRO
“We are excited about the R&D progress we are going to make with TIPT over the next 6 – 8 months while waiting to receive our Dealer’s License from Health Canada. We will be well prepared for our move into the controlled substances world of psychedelics and will have advanced knowledge regarding psilocybin and its associated novel delivery mechanisms.”Ben Nikolaevsky, Pure Extracts CEO
Pure Extracts last traded at $0.62 on the CSE.
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