Hello, 

Thank you for your inquiry. I do believe Steve has touched on this topic in recent interviews;  The recall of the sample tests that were sent out are not at all related to KAI nor will they have any impact on the MDEL application. These are two seperate matters and the recall does not remove pharma from the application process. Receiving the MDEL licence will give us the ability to import, sell and distribute medial devices in Canada to Canadians. We are optimistic in the timing of this.