Moxa,
As I see it, many cancer drugs are used off label on both different cancers, or in combinations with other drugs not established in the trial protocol. If the benefits are anecdotally demonstrated to be strong, the drug maker often chooses to do additional trials to expand the drug label. It's my understanding that in most cases once approved, the drugs will usually be paid for by insurance companies for off label use, though additional justification may be required by the Doctor using the drug.
As I see it, the same logic should apply to use of our psoriasis cream for other skin diseases once it's approved. If without reformulation anecdotal use shows it works for acne, eczema, etc. I believe it can gain insurance coverage without full trials being done, but in time the company may wish to gain the label expansion by doing full trials. Of course the other possibility is that other diseases would be better served by different formulations which would require new patents, trials, etc.
It's my belief that many different formulations using cannabis and other things may have benefits for psoriasis and a variety of skin diseases. I doubt if our patent coverage would be so inclusive that virtually all other formulations that use cannabis in any way would violate it. What I don't know is just how close another product may come and not violate the patent.
There are currently products on or about to enter the market that have various cannabis components in cream for treatment of a variety of skin conditions, it's very possible that some may violate our patents, but I'm unsure what, if anything can be done while the patents are pending.
Our cream will probably be on the market in cannabis stores before drug approval permits it to be sold in drug stores everywhere. If I were designing the sales program, I would certainly provide some incentives to people using it to provide feedback on how it's working which would hopefully gather data that's anecdotal in nature but should cover all sorts of skin diseases, not just psoriasis, as people could purchase the cream without specific prescription in cannabis stores. As I understand it, in State's where only medical cannabis is available, patients get prescriptions to use cannabis that are general, permitting them to purchase anything in the store.
Having products with clinically proven efficacy certainly provide a tremendous advantage in generating sales. I would think that if OWCP's cream gained FDA approval, it would dominate the market as even if other creams were available, it would be the one that Insurance companies should pay for. I would think that if in the past they paid for others, once one was approved, insurance companies and Doctors would opt to use the FDA approved product. It may take awhile to get there, but gaining drug approvals should always be the goal.
Gary
As I see it, many cancer drugs are used off label on both different cancers, or in combinations with other drugs not established in the trial protocol. If the benefits are anecdotally demonstrated to be strong, the drug maker often chooses to do additional trials to expand the drug label. It's my understanding that in most cases once approved, the drugs will usually be paid for by insurance companies for off label use, though additional justification may be required by the Doctor using the drug.
As I see it, the same logic should apply to use of our psoriasis cream for other skin diseases once it's approved. If without reformulation anecdotal use shows it works for acne, eczema, etc. I believe it can gain insurance coverage without full trials being done, but in time the company may wish to gain the label expansion by doing full trials. Of course the other possibility is that other diseases would be better served by different formulations which would require new patents, trials, etc.
It's my belief that many different formulations using cannabis and other things may have benefits for psoriasis and a variety of skin diseases. I doubt if our patent coverage would be so inclusive that virtually all other formulations that use cannabis in any way would violate it. What I don't know is just how close another product may come and not violate the patent.
There are currently products on or about to enter the market that have various cannabis components in cream for treatment of a variety of skin conditions, it's very possible that some may violate our patents, but I'm unsure what, if anything can be done while the patents are pending.
Our cream will probably be on the market in cannabis stores before drug approval permits it to be sold in drug stores everywhere. If I were designing the sales program, I would certainly provide some incentives to people using it to provide feedback on how it's working which would hopefully gather data that's anecdotal in nature but should cover all sorts of skin diseases, not just psoriasis, as people could purchase the cream without specific prescription in cannabis stores. As I understand it, in State's where only medical cannabis is available, patients get prescriptions to use cannabis that are general, permitting them to purchase anything in the store.
Having products with clinically proven efficacy certainly provide a tremendous advantage in generating sales. I would think that if OWCP's cream gained FDA approval, it would dominate the market as even if other creams were available, it would be the one that Insurance companies should pay for. I would think that if in the past they paid for others, once one was approved, insurance companies and Doctors would opt to use the FDA approved product. It may take awhile to get there, but gaining drug approvals should always be the goal.
Gary
