RE:On Nuuvera and GMP certification great DD, I just want to make sure I have connected the dots...
Tetra on a GMP certified lab for PPP0001
Tetra received approval for the ethics review board on November 6th and subsequently submitted a Clinical Trial Application (CTA) for its Phase 3 clinical trial in cancer patients. This trial is expected to be a landmark clinical trial and is the first of its kind, enrolling a total of 946 subjects. Dr Guy Chamberland, Tetra's Chief Scientific Officer (CSO) commented that: "a GMP certification from Health Canada's drug inspectorate is welcome as this certification will signal to the company that its manufacturing partners comply with GMP requirements for drug approval and increases the measures put in place to ensure patients' safety." Once the trial is initiated, The Company will accelerate enrolment by expanding the number of clinical sites as it aims to adhere to its target date for filing PPP001 as a prescription drug (with a drug identification number - DIN) to Health Canada.
Nuuvera aquires Medalchemy on January 24th - Medalchemy has a GMP certified lab
ORONTO, Jan. 24, 2018 /CNW/ - Nuuvera Inc. ("Nuuvera") (TSXV:NUU), is pleased to announce that it has signed a Letter of Intent ("LOI") with Medalchemy S.L. ("Medalchemy") to acquire a majority interest in its fully-licensed, GMP certified laboratory located in Alicante, Spain.
https://www.newswire.ca/news-releases/nuuvera-signs-letter-of-intent-to-acquire-gmp-certified-lab-in-spain-670881973.html
Aphria aquires Medalchemy on January 29th
- Provides Access to State-of-the-Art Testing and Extraction Facilities : The combined company, through Nuuvera, has access to the only standalone Health Canada GMP-approved facility that is authorized and dedicated under its controlled drugs and substances licence to conduct commercial scale activities with respect to cannabis and cannabinoids. This state-of-the-art medical laboratory enables Nuuvera to maintain the highest standards by adhering to both Health Canada and FDA pharmaceutical GMP guidelines, ensuring product safety, quality, and efficacy.
https://aphria.ca/blog/global-leader-in-medical-cannabis-created-by-aphria-and-nuuvera-combination/