RE:could be the reason for test, PP001I it’s not late news read the last paragraph
We appreciate your comments. Tetra Bio-Pharma is committed to transparency and compliance.
Tetra, acted in accordance with all requirements of the Food and Drugs Act and Good Manufacturing Practices once we detected the presence of mycotoxins other than aflatoxin on December 20th, 2018 in the experimental lot used for the validation of the raw cannabis.
This led to the analyses of every lot being used in our clinical trials to verify for the presence of two other types of mycotoxins (Ochratoxin A, and DON (Deoxynivalenol; Vomitoxin) and the inclusion of this testing into the product specifications.
The report received on Dec 20th, 2018 was for the experimental lot used for the validation and did not include the product used in the phase 3 clinical trial.
Treatment was suspended as part of the regulatory process.
Reports for the first set of clinical lots (product used in the clinical trial) were received on Jan 22nd and then Feb 1st, 2019.
Subsequent to the reports being submitted, the press release needed to be drafted and approved by a number of parties, including Health Canada and was issued at the earliest possible time.