While I frankly believe that management could tell us far more than they do, I've seen much the same from many other companies. I suspect they know their are things they need to do before they can truly answer our questions without seeming evasive.
Unfortunately, any time a company is in discussions with other companies they're normally operating under confidentiality agreements. In most cases, companies at least admit that's the case, but not always.
At this point you have to believe that OWCP is working to get one or more companies to replace Medmar in the U.S. They can't speak about it because of confidentiality agreements until at least they have something to announce. At that point we may learn if the have an agreement for one State, a few States, or if someone is committing to get the job done in every state.
I'd like to see the company update us on the safety trial. The clinical data site has not been updated since last November. It's my understanding that someone was told they didn't update it since it was never their intent to enroll patients from the U.S. I don't believe that they couldn't have clearly stated that Israel was the only place where the trial was being done, and as of today, or hopefully a month ago, the trial is fully enrolled, which would mean it could end in late June or early July.
I do expect that we'll see some major news in the next month or so, but until safety is established, I doubt if their will be a commitment to initiate a sales program in any country. If the safety profile indicates that no caution is needed in using the cream, we could see sales initiated within weeks or months. If on the other hand their are some cautions which must be observed in using the cream, than the FDA or similar agencies in the Countries or States where the cream is to be marketed would need to agree to how the cautions are to be dealt with.
I believe the company knows that no problem will be found that makes the cream so unsafe it cannot be marketed, but with all the blood testing they're doing, their could be recommendations as to how much can be used over a given period of time, and that could vary from government to government, depending on their position on cannabis. If our FDA accepts the cream as being completely safe, I believe it will be accepted everywhere.
Sales of course will be the really big news, and I'm not among those who believe that sales will be stifled until FDA efficacy trials approve the products as drugs. I suspect the opposite could be true if results of the use of the products can easily be reported and demonstrate anecdotal efficacy that cannot be denied. I recently saw where a court ordered an insurance company to pay for a cannabis base drug that was benefitting a patient. I believe that our cream, as well as the sublingual tablets could prove so effective that similar court rulings could occur before an efficacy trial could be completed.
If anecdotal efficacy is shown in psoriasis, acne, excema, etc it's very possible that Insurance might see that treatment with our cream may be cheaper for them than the drugs currently being used, which are covered by insurance. I believe if you give the insurance companies a lower cost option, they may agree to provide coverage without FDA approval, perhaps even without court action. Much the same is probably true with the sublingual tablet as it's tried on people with PTSD, autism, etc. The key is lots of anecdotal evidence of efficacy.
Gary
