I don't see us as being out of the recreational cannabis market. It's my belief that once we have clinical evidence of efficacy, but not yet drug approval, the company will market products in cannabis marketplaces, and that would include where recreational cannabis can be sold without a script.
The difference between us, and most other cannabis based companies, is we'll have clinical trials demonstrating our products work. In many cases, the Pivotal trials which are required to gain FDA and other approvals take years to in some cases over a decade. Such trials may be needed for our multiple myeloma product if it's to be administered in hospitals, but even that product could be available in cannabis stores if it's to be taken at home with sufficient evidence of efficacy.
I've spoken with several Doctors who don't openly encourage patients to use cannabis, but if asked, they'll often suggest that patients are free to try it, and sometimes even encourage it. Most won't write cannabis scripts, which here in California make it cheaper to purchase. My point is, run clinical trials that clearly show efficacy, publicize results at both technical conferences and other investors and other presentation, then make the product available. The income from sales can work toward the costs of running the Phase 3 Trials that will gain drug approval, if deemed necessary.
Note, my reason for saying if deemed necessary is based on insurance companies paying at least part of the cost of prescribed drugs. There is another possibility. In some cases the courts have instructed Insurance companies to pay for cannabis based drugs where clear benefits were proven. If this in fact became the practice, if Insurance companies had to pay for prescribed cannabis products even though they were not FDA approved, there might be no reason to spend the money required for FDA approval. I'm not saying this will happen, but between right to try initiatives, and looking to reduce medical costs, I suspect that insurance companies may go along with such actions if it can be shown that use of cannabis based products could actually lower the cost of treatment of a specific disease.
As I understand it, the prescription drugs for psoriasis are quite expensive, as well as having some very negative side effects. If our cream provided an alternative with fewer or no side effects at lower cost than the prescription drug and was proven in Phase 2 Trials, I don't know that Insurance companies wouldn't go along with it's use. I suspect that in some countries the Phase 2 Trial might actually gain approval, but I doubt that would be true of the U.S.
Gary
The difference between us, and most other cannabis based companies, is we'll have clinical trials demonstrating our products work. In many cases, the Pivotal trials which are required to gain FDA and other approvals take years to in some cases over a decade. Such trials may be needed for our multiple myeloma product if it's to be administered in hospitals, but even that product could be available in cannabis stores if it's to be taken at home with sufficient evidence of efficacy.
I've spoken with several Doctors who don't openly encourage patients to use cannabis, but if asked, they'll often suggest that patients are free to try it, and sometimes even encourage it. Most won't write cannabis scripts, which here in California make it cheaper to purchase. My point is, run clinical trials that clearly show efficacy, publicize results at both technical conferences and other investors and other presentation, then make the product available. The income from sales can work toward the costs of running the Phase 3 Trials that will gain drug approval, if deemed necessary.
Note, my reason for saying if deemed necessary is based on insurance companies paying at least part of the cost of prescribed drugs. There is another possibility. In some cases the courts have instructed Insurance companies to pay for cannabis based drugs where clear benefits were proven. If this in fact became the practice, if Insurance companies had to pay for prescribed cannabis products even though they were not FDA approved, there might be no reason to spend the money required for FDA approval. I'm not saying this will happen, but between right to try initiatives, and looking to reduce medical costs, I suspect that insurance companies may go along with such actions if it can be shown that use of cannabis based products could actually lower the cost of treatment of a specific disease.
As I understand it, the prescription drugs for psoriasis are quite expensive, as well as having some very negative side effects. If our cream provided an alternative with fewer or no side effects at lower cost than the prescription drug and was proven in Phase 2 Trials, I don't know that Insurance companies wouldn't go along with it's use. I suspect that in some countries the Phase 2 Trial might actually gain approval, but I doubt that would be true of the U.S.
Gary
