Farmer,
If they are truly planning on selling the cream in California this year, I can only believe they have at least one company that's ready to partner with them for those rights. My thinking is that they are waiting to announce such a partnership for one of two things. Safety is the first, the trial ending this quarter, if it's on time, will give us that. Efficacy is the second, and discussion seems to say they may be into a Phase 2 already, but I certainly have no proof of that.
From the discussions on chat sites, the Phase 2 portion is a simpler trial than Phase 1. Knowing the drug is safe, people with psoriasis may be using the drug Phase 2 and photographic evidence of efficacy may be all that's needed over some period of time. I don't know the time, but I believe a matter of a few weeks should show improvement, and at most a few months should show that the improvement is sustained. In short, perhaps it's possible to end such a trial, or at least get a peek at the data, by fourth quarter. The partnership could come either after safety is proven, or efficacy is seen, and still would be possible this year.
Of course, it is also possible for the partner to happen now, and I'm not certain that the company couldn't sell the product in California in cannabis stores without proof of either safety or efficacy. I believe they'd be foolish not to know the product is safe, but efficacy could actually be borne out by feedback from customers trying the product, perhaps with a money back guarantee that they would have to live with. I believe the company is reasonably certain that they'll see efficacy, so they might be willing to back up such a guarantee. If I were establishing a sales campaign for the product, I'd certainly try to solicit feedback by providing a coupon to purchase more of the product at a discount to people who submitted proof of how well it was working. All these things could be done electronically with photo's sent to the company, showing the improvement, and coupons transmitted electronically that could be redeemed in cannabis stores. Effectively the customers who tried it would be doing an anecdotal trial of the product. Frankly, even if the Phase 2 trial was completed successfully, and efficacy was well demonstrated, I would still look to gather information from customers using it, it would be anecdotal evidence, but sometimes the FDA can be swayed to approve a drug with a whole lot of anecdotal evidence, as well as completed Phase 2 Trials.
Gary
If they are truly planning on selling the cream in California this year, I can only believe they have at least one company that's ready to partner with them for those rights. My thinking is that they are waiting to announce such a partnership for one of two things. Safety is the first, the trial ending this quarter, if it's on time, will give us that. Efficacy is the second, and discussion seems to say they may be into a Phase 2 already, but I certainly have no proof of that.
From the discussions on chat sites, the Phase 2 portion is a simpler trial than Phase 1. Knowing the drug is safe, people with psoriasis may be using the drug Phase 2 and photographic evidence of efficacy may be all that's needed over some period of time. I don't know the time, but I believe a matter of a few weeks should show improvement, and at most a few months should show that the improvement is sustained. In short, perhaps it's possible to end such a trial, or at least get a peek at the data, by fourth quarter. The partnership could come either after safety is proven, or efficacy is seen, and still would be possible this year.
Of course, it is also possible for the partner to happen now, and I'm not certain that the company couldn't sell the product in California in cannabis stores without proof of either safety or efficacy. I believe they'd be foolish not to know the product is safe, but efficacy could actually be borne out by feedback from customers trying the product, perhaps with a money back guarantee that they would have to live with. I believe the company is reasonably certain that they'll see efficacy, so they might be willing to back up such a guarantee. If I were establishing a sales campaign for the product, I'd certainly try to solicit feedback by providing a coupon to purchase more of the product at a discount to people who submitted proof of how well it was working. All these things could be done electronically with photo's sent to the company, showing the improvement, and coupons transmitted electronically that could be redeemed in cannabis stores. Effectively the customers who tried it would be doing an anecdotal trial of the product. Frankly, even if the Phase 2 trial was completed successfully, and efficacy was well demonstrated, I would still look to gather information from customers using it, it would be anecdotal evidence, but sometimes the FDA can be swayed to approve a drug with a whole lot of anecdotal evidence, as well as completed Phase 2 Trials.
Gary
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