Contrary to the information that STENOCARE first received from its partner and supplier, CannTrust, about the origin of product batches supplied by CannTrust, STENOCARE has early this morning received additional documentation from CannTrust that indicates that an additional part of the products in STENOCAREs inventory, which has been sold to the market since June 10, 2019 were sourced from the production rooms at CannTrust, that were not yet approved at the time of production. STENOCARE is in dialogue with the Danish Medicines Agency about this new situation.
Early this morning, STENOCARE received new and more detailed information from CannTrust which indicates that most, yet not all, of the CannTrust products that STENOCARE has in inventory and that STENOCARE has supplied to the Danish market since June 10, 2019 were cultivated in the production rooms at CannTrust that were not approved at the time of production (between October 2018 and March 2019).
As a result of the new information, all products delivered from STENOCARE relating to the batches in question will be put in quarantine, which means that they will be isolated and blocked from being sold until the Canadian health authorities, Health Canada and the Danish Medicines Agency have concluded in the matter.
The most likely consequences from this new situation is that there will be a temporary shortage of medical cannabis products to the Danish market. This will have negative financial consequences to STENOCARE irrespective of the fact that CannTrust is contractually committed to deliver fully licensed and approved products to STENOCARE.
This matter relates to a total of 5 batches, of which STENOCARE was first informed of one, that were produced during the period from October 2018 and March 2019 in 5 new production rooms at CannTrust that were not yet approved by the Canadian authorities. All products delivered by CannTrust before and after are unrelated to this matter and CannTrust has been producing fully approved products from all of its facilities since April 2019.
It is important to stress, that all products supplied 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.
Irrespective of that, STENOCARE considers this matter with utmost severity and is in close dialogue with the Danish Medicines Agency to secure that all necessary actions are taken.
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 11, 2019.