All batches of products received by STENOCARE from CannTrust, but one, are unrelated to the current issue. The related batch, very small and still in stock, has been identified and is put in quarantine. This is not expected to have any negative impact on patients nor STENOCARE.
Yesterday, STENOCARE’s partner in Canada, CannTrust released a Statement Regarding Health Canada Audit. Link to message: https://canntrust.com/canntrust-statement-regarding-health-canada-audit/.
What is this?
Unauthorized production took place in five new cultivation rooms at the CannTrust facility during October 2018 and until March 2019. All CannTrust products, no matter where and when they have been cultivated, are subject to full external laboratory control. CannTrust has stated that they are now awaiting new tests on the involved products and thereafter the response from the Authorities, due in about two weeks. Depending upon the nature of the response, CannTrust may face temporary irregularity in through-put, despite of the fact that CannTrust continues to cultivate medical cannabis products at full capacity from its wide range of fully authorized locations – including the five new rooms that were approved for cultivation in April 2019.
What does this mean to STENOCARE?
STENOCARE deals with any issues relating to quality and approval of products with the greatest level of attention and seriousness. STENOCAREs first priority is and will always be patient safety. All products that are sourced from CannTrust have been tested for all the required quality standards, and independent third- party Lab analysis has documented this prior to receiving the products into the STENOCARE warehouse in Denmark. Therefore, this matter does not point to any negative consequences to patient safety.
Together with CannTrust all product batches received by STENOCARE over time have now been investigated to establish if cultivation originates from any of the non-compliant rooms. It has been concluded, that all batches shipped to STENOCARE, except from one small batch, have been cultivated in compliant rooms. STENOCARE has been in contact with the Danish Medicines Agency, and the single, non-compliant small batch has been put in quarantine for potential destruction, pending the outcome of the ongoing investigation by Health Canada.
STENOCARE operates with a significant inventory, which means that most likely this matter will have no impact upon STENOCARE’s continued ability to serve the market as required. In summary, this means that STENOCARE expects to be unharmed financially or otherwise from this unfortunate matter.
This information is information that STENOCARE A/S is obliged to publish in accordance with the EU Market Abuse Regulation. The information was provided by the contact person above for publication on July 9, 2019.