Farmer,
While I generally agree with you, I believe that OWCP, not Mediq, should be establishing the guidance, not only for Germany, but worldwide.
I believe that OWCP is misleading all of us if they never intended to market any product that's market ready until it's been in what amount to Phase 2 efficacy testing. On the other hand, they may have been misled themselves about putting product into sales without such trials, at least in certain countries.
For all we know, they're in discussion with people who can put the cream, or the sublingual tablet, into sales in a given State or Country without further testing. I understand that Mediq is working on Germany, and intends to expand through Europe, but I don't know that they have exclusive rights in all European countries.
Frankly, selling the cream after some clinical trials were done with diseased patients would be far easier if you have both testimonials and pictures of the benefits patients received. On the other hand, if the company offered serious discounts to patients who'd try the cream and report results, perhaps with a money back guarantee if significant benefit isn't seen, they could be very successful in initiating such a campaign.
I'm of the belief that after safety is proven, because of the nature of the cannabis industry, the cream could be sold without further trials. While this wouldn't be the case with drugs, as I understand it, it is the case with all sorts of products made from naturally occurring things. Be it fish oil extracted from anything from Krill to any fish you could name, it can be sold as having the benefits of Omega C. Much the same can be said for all sorts of vitamin and mineral products on sale everywhere, and essentially all the products found in stores selling legal marijuana. In fact, I doubt that even safety has been proven in many of these products to anywhere near the degree of the Phase 1 Trial being done with our cream. Please not, I haven't said psoriasis cream because I believe the cream in it's current form will be proven effective in many other skin conditions.
I believe the sublingual tablet may not even require a safety trial if the company shows it is essentially made of compositions that previously have been tested, just not in precisely the form it has in the tablet. I believe that's the logic behind virtually a myriad of vitamins, minerals, and other nutriceuticals that are on the market.
Of course the company want to be known as a Biotech, so the conflict may be purely an internal one. Run at least the equal of Phase 2 Trials, then market the product, and you're acting like a Biotech. Run just a safety trial, and perhaps you're exceeding what a cosmetic company does, but it's difficult to say you're a biotech.
I believe the truth is, to go after a disease like Multiple Myeloma, they'll need full clinical trials, and there they'll be a Biotech. However, they can do far less rigorous testing and put the product in sales for the likes of psoriasis, acne, PTSD, etc. and collect anecdotal evidence of efficacy that can be used to build sales, and perhaps eventually actually get drug approval. In that Courts have ordered Insurance Companies to pay for certain treatment with cannabis based products, it's certainly possible with enough anecdotal evidence to get insurance to pay.
In reality, I believe that time will show that treatment with cannabis based products are more effective and less expensive than drugs currently on the market. If this is truly the case, Insurance Companies won't fight to hard to not pay for this treatment. It will take time to prove this is a fact, but when it's clear, it will be accepted.
Gary
While I generally agree with you, I believe that OWCP, not Mediq, should be establishing the guidance, not only for Germany, but worldwide.
I believe that OWCP is misleading all of us if they never intended to market any product that's market ready until it's been in what amount to Phase 2 efficacy testing. On the other hand, they may have been misled themselves about putting product into sales without such trials, at least in certain countries.
For all we know, they're in discussion with people who can put the cream, or the sublingual tablet, into sales in a given State or Country without further testing. I understand that Mediq is working on Germany, and intends to expand through Europe, but I don't know that they have exclusive rights in all European countries.
Frankly, selling the cream after some clinical trials were done with diseased patients would be far easier if you have both testimonials and pictures of the benefits patients received. On the other hand, if the company offered serious discounts to patients who'd try the cream and report results, perhaps with a money back guarantee if significant benefit isn't seen, they could be very successful in initiating such a campaign.
I'm of the belief that after safety is proven, because of the nature of the cannabis industry, the cream could be sold without further trials. While this wouldn't be the case with drugs, as I understand it, it is the case with all sorts of products made from naturally occurring things. Be it fish oil extracted from anything from Krill to any fish you could name, it can be sold as having the benefits of Omega C. Much the same can be said for all sorts of vitamin and mineral products on sale everywhere, and essentially all the products found in stores selling legal marijuana. In fact, I doubt that even safety has been proven in many of these products to anywhere near the degree of the Phase 1 Trial being done with our cream. Please not, I haven't said psoriasis cream because I believe the cream in it's current form will be proven effective in many other skin conditions.
I believe the sublingual tablet may not even require a safety trial if the company shows it is essentially made of compositions that previously have been tested, just not in precisely the form it has in the tablet. I believe that's the logic behind virtually a myriad of vitamins, minerals, and other nutriceuticals that are on the market.
Of course the company want to be known as a Biotech, so the conflict may be purely an internal one. Run at least the equal of Phase 2 Trials, then market the product, and you're acting like a Biotech. Run just a safety trial, and perhaps you're exceeding what a cosmetic company does, but it's difficult to say you're a biotech.
I believe the truth is, to go after a disease like Multiple Myeloma, they'll need full clinical trials, and there they'll be a Biotech. However, they can do far less rigorous testing and put the product in sales for the likes of psoriasis, acne, PTSD, etc. and collect anecdotal evidence of efficacy that can be used to build sales, and perhaps eventually actually get drug approval. In that Courts have ordered Insurance Companies to pay for certain treatment with cannabis based products, it's certainly possible with enough anecdotal evidence to get insurance to pay.
In reality, I believe that time will show that treatment with cannabis based products are more effective and less expensive than drugs currently on the market. If this is truly the case, Insurance Companies won't fight to hard to not pay for this treatment. It will take time to prove this is a fact, but when it's clear, it will be accepted.
Gary
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