I think we all need to recognize something, OWCP i
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Posted On: 03/25/2018 11:07:37 PM
I think we all need to recognize something, OWCP is taking a dual path with most, if not all the products they're creating. In one path the products will eventually be put through whatever trials are needed to have the product approved as a drug, that frequently takes a decade from the genesis of the product through approval.
It's the other path that's not yet completely clear, that of bringing the product to market in places where cannabis can be sold. What's not clear is at what point the products will come to market. I believe it's pretty clear that the company wants to at least prove the product safe, and they're running safety trials in protocols that should be acceptable to our FDA. The question, which might be answered shortly is do they put it on the marketplace after demonstrating safety, or do they wait for preliminary efficacy testing, typically Phase 2 or the Phase 2 portion of a Phase 1/2 Trial. Much might be determined by the patient mix in the Phase 1, if they don't have the condition the product is intended for, clearly it takes a Phase 2 to show efficacy. On the other hand if they start Phase 1 with patients having the disease, efficacy could be seen in Phase 1 and verified in the Phase 2 portion if the trial is a Phase 1/2.
The point is, if no efficacy is required, we might be selling the psoriasis cream before the end of the next quarter. If efficacy must be demonstrated, we'll be lucky to initiate sales this year. While this isn't terrible, it's a delay that investor's won't welcome. The positive of such an approach would be that claims could be made about efficacy.
If I had my way the cream would go on the market after proven safety, but all who purchase it would get two things, one would be a money back guarantee if their condition didn't improve. The second would be the ability to discount their next order by providing feedback about how the drug was working by answering a questionnaire about it on a website that all could look at to access how well it's working for others. People could get a codename if they didn't want their identity to be revealed. Pictures before and after should get an added bonus on the site. JMHO.
Gary
It's the other path that's not yet completely clear, that of bringing the product to market in places where cannabis can be sold. What's not clear is at what point the products will come to market. I believe it's pretty clear that the company wants to at least prove the product safe, and they're running safety trials in protocols that should be acceptable to our FDA. The question, which might be answered shortly is do they put it on the marketplace after demonstrating safety, or do they wait for preliminary efficacy testing, typically Phase 2 or the Phase 2 portion of a Phase 1/2 Trial. Much might be determined by the patient mix in the Phase 1, if they don't have the condition the product is intended for, clearly it takes a Phase 2 to show efficacy. On the other hand if they start Phase 1 with patients having the disease, efficacy could be seen in Phase 1 and verified in the Phase 2 portion if the trial is a Phase 1/2.
The point is, if no efficacy is required, we might be selling the psoriasis cream before the end of the next quarter. If efficacy must be demonstrated, we'll be lucky to initiate sales this year. While this isn't terrible, it's a delay that investor's won't welcome. The positive of such an approach would be that claims could be made about efficacy.
If I had my way the cream would go on the market after proven safety, but all who purchase it would get two things, one would be a money back guarantee if their condition didn't improve. The second would be the ability to discount their next order by providing feedback about how the drug was working by answering a questionnaire about it on a website that all could look at to access how well it's working for others. People could get a codename if they didn't want their identity to be revealed. Pictures before and after should get an added bonus on the site. JMHO.
Gary
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