As a private corporation, there is not a lot “out there” in public domain so to the degree that you can answer this please do. Let’s start at 10,000 feet and zoom in fast. A sore point for Canadians that have moved away from traditional pharmaceutical drugs to cannabis is how it is treated as medicine. It is not formally recognized as medicine by Health Canada. There is not a DIN (so for most no medical benefits coverage), it is taxed with excise taxes and HST, and the list goes on. Another interesting point is that the Cannabis Act forbids speaking to health benefits and claims so between that and the other reasons mentioned (no DIN etc) … we see why some Doctors and Nurse Practioners being reluctant to issue the medical documentation required for patients to procure medical cannabis.
A formulation in a reliable delivery method that ensure consistent dosing is believed by many as one of the precursors towards the issuance of a DIN. Are you looking at such a formulation and delivery method (capsules are often sited)? Regardless, do you see in the not too distant future the issuance of a DIN to specific formulations?
What you are describing is the key trade-off. In Canada, we can launch products without a DIN under the definition of The Cannabis Act. That definition has expanded several from dried and then added oil and capsules. With the regulatory changes for edibles anticipated later this year, we anticipate we will see a broadened definition once again.
What that means for us is a strategic decision on whether to launch products under the cannabis definition. In this case, we give up some opportunities to make a therapeutic claim. In traditional pharma terms, that means marketing the product like an OTC product rather than requiring a prescription. That approach requires less investment, but we are also considering approaches that will see us achieving DINs for specific formulations. In both cases, Scientus is investing capital and resources to conducting clinical studies. We believe that is essential for physicians and patients with real needs to know they are getting real treatment. However, pursuing DIN approvals requires more expensive studies. We intend to partner with global pharma companies to do that. And as reimbursement becomes available, we will accelerate these strategies.
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