It's my belief that the company is taking a dual p
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Posted On: 05/11/2017 12:31:44 AM
It's my belief that the company is taking a dual path on many of its products.
Path one is essentially the same that any Biotech or Pharma takes for drug approval. I.E. Preclinical development followed by a Phase 1 Trial intended to determine safety and effective dosage, then a Phase 2 which verifies efficacy in a small sampling of patients, and finally a Phase 3 in a larger sampling intended for approval of the FDA and other agencies. These trials are the ones which easily can take 2 to 3 years, or substantially more.
Path two is the path used for products being sold in Green Cross stores if it's cannabis based, as well as all sorts of vitamins, minerals, and all sorts of other supplements sold in drug and other stores that have not been through full efficacy testing, but have either been tested and determined safe, or are made of compounds that previously been proven safe.
I believe that OWCP has products traveling down both paths simultaneously. Their psoriasis cream should be marketed on completion of the Phase 1 safety trial that's currently being run with healthy patients. Once they have a source who'll manufacture, distribute and sell in the U.S. it will be sold in Green Cross stores. Existing contracts should permit it to be sold in other countries.
At the same time, OWCP will be initiating new Phase 2 or 3 Trials intended to gain approval as a drug for psoriasis and other skin diseases from the FDA, these are the trials that could take years. The advantage of such trials would be that approval would permit sales virtually everywhere, and Insurance could cover a substantial part of the price.
I believe that the same is true of the sublingual tablet, and many of the other products OWCP is developing. It may be utilized for attitude adjustment, PTSD, etc without the Phase 2 and 3 Trials, and while it may work for multi myeloma, proof of that will only be established by Phase 2/3 efficacy trials that will take years. Once the tablets are available in Green Cross stores nothing will prevent patients with MM from acquiring them, but until clinical trials prove they work, they'll not be a part of the SOC for treating the disease.
Gary
Path one is essentially the same that any Biotech or Pharma takes for drug approval. I.E. Preclinical development followed by a Phase 1 Trial intended to determine safety and effective dosage, then a Phase 2 which verifies efficacy in a small sampling of patients, and finally a Phase 3 in a larger sampling intended for approval of the FDA and other agencies. These trials are the ones which easily can take 2 to 3 years, or substantially more.
Path two is the path used for products being sold in Green Cross stores if it's cannabis based, as well as all sorts of vitamins, minerals, and all sorts of other supplements sold in drug and other stores that have not been through full efficacy testing, but have either been tested and determined safe, or are made of compounds that previously been proven safe.
I believe that OWCP has products traveling down both paths simultaneously. Their psoriasis cream should be marketed on completion of the Phase 1 safety trial that's currently being run with healthy patients. Once they have a source who'll manufacture, distribute and sell in the U.S. it will be sold in Green Cross stores. Existing contracts should permit it to be sold in other countries.
At the same time, OWCP will be initiating new Phase 2 or 3 Trials intended to gain approval as a drug for psoriasis and other skin diseases from the FDA, these are the trials that could take years. The advantage of such trials would be that approval would permit sales virtually everywhere, and Insurance could cover a substantial part of the price.
I believe that the same is true of the sublingual tablet, and many of the other products OWCP is developing. It may be utilized for attitude adjustment, PTSD, etc without the Phase 2 and 3 Trials, and while it may work for multi myeloma, proof of that will only be established by Phase 2/3 efficacy trials that will take years. Once the tablets are available in Green Cross stores nothing will prevent patients with MM from acquiring them, but until clinical trials prove they work, they'll not be a part of the SOC for treating the disease.
Gary
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