I believe the Mediq information was the key to today's weakness, however had we listened to what OWCP had been saying, it should have been anticipated. Why? Because to begin with, OWCP views itself to be a biotech, and as such months ago said they'd be running several trials on a variety of skin diseases. A cosmetic supplier might have put a product in the marketplace without proof that it works, but a biotech wouldn't.
That being said, I really don't believe that in Germany, or elsewhere, full efficacy trials with complete Govt. approval are possible in 3 to 6 months. I'm no expert on such trials, so if you think I'm wrong, please feel free to say so. If I'm correct, I believe Mediq's intention is to have sufficient proof of concept to provide evidence of why people should purchase the cream from a supplier of cannabis based products in Germany, and ultimately elsewhere.
Here in the U.S., if full efficacy trials were run, on completion the FDA would receive an NDA or BLA with all the support for approving the drug. At that point, the FDA would have either 6 months, or one year to review the information and decide whether to approve it, deny it, or request further information, which once answered would give them another 6 months or a year to evaluate the submission again. In short, it takes at least a few years to gain approval here. I very much doubt if German approval can be obtained in 3 to 6 months on trials that are yet to start.
I believe that their are many other positive things which may occur prior to sufficient clinical data is developed to support sales. I believe much of what could be very positive for OWCP depends on the acts of others, so the timing is completely unpredictable without further guidance. I'm speaking about such things as partnerships, or other types of collaborations that do many things. For one, we could get single State, or multiple state arrangements for the manufacture, distribution and sales in the U.S.
I believe the entire cannabis industry has been punished by some of Jeff Session's beliefs. I'm not suggesting that he should be ignored, but we need to remember that at most the U.S. represents 35% of the market. Much of the 65% that remains is in countries that have already legalized marijuana. OWCP is truly an international company, it could easily have substantial sales outside the U.S. before it's first sale was made here. Congress has at least a few legislative actions that tell Session's to keep hands off in State's where medical marijuana is legal. Unfortunately, to date, Congress hasn't taken the action to change how cannabis is characterized which would truly take all the wind out of Session's sails.
I'm not suggesting we ignore the U.S. but I am suggesting that the company could be a tremendous success before sales in the U.S. are initiated.
I would hope that OWCP provides far better guidance in their next quarterly release, and really hope they host a webcast that's open to questions from at least any Analyst who's following the company. I have no doubt that if Mediq can truly run trials and establish sales in 3 to 6 months, when sales are established, OWCP will be trading at a substantial multiple of where it's trading today.
Gary
That being said, I really don't believe that in Germany, or elsewhere, full efficacy trials with complete Govt. approval are possible in 3 to 6 months. I'm no expert on such trials, so if you think I'm wrong, please feel free to say so. If I'm correct, I believe Mediq's intention is to have sufficient proof of concept to provide evidence of why people should purchase the cream from a supplier of cannabis based products in Germany, and ultimately elsewhere.
Here in the U.S., if full efficacy trials were run, on completion the FDA would receive an NDA or BLA with all the support for approving the drug. At that point, the FDA would have either 6 months, or one year to review the information and decide whether to approve it, deny it, or request further information, which once answered would give them another 6 months or a year to evaluate the submission again. In short, it takes at least a few years to gain approval here. I very much doubt if German approval can be obtained in 3 to 6 months on trials that are yet to start.
I believe that their are many other positive things which may occur prior to sufficient clinical data is developed to support sales. I believe much of what could be very positive for OWCP depends on the acts of others, so the timing is completely unpredictable without further guidance. I'm speaking about such things as partnerships, or other types of collaborations that do many things. For one, we could get single State, or multiple state arrangements for the manufacture, distribution and sales in the U.S.
I believe the entire cannabis industry has been punished by some of Jeff Session's beliefs. I'm not suggesting that he should be ignored, but we need to remember that at most the U.S. represents 35% of the market. Much of the 65% that remains is in countries that have already legalized marijuana. OWCP is truly an international company, it could easily have substantial sales outside the U.S. before it's first sale was made here. Congress has at least a few legislative actions that tell Session's to keep hands off in State's where medical marijuana is legal. Unfortunately, to date, Congress hasn't taken the action to change how cannabis is characterized which would truly take all the wind out of Session's sails.
I'm not suggesting we ignore the U.S. but I am suggesting that the company could be a tremendous success before sales in the U.S. are initiated.
I would hope that OWCP provides far better guidance in their next quarterly release, and really hope they host a webcast that's open to questions from at least any Analyst who's following the company. I have no doubt that if Mediq can truly run trials and establish sales in 3 to 6 months, when sales are established, OWCP will be trading at a substantial multiple of where it's trading today.
Gary
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