I suppose that it's my contention that they don't control, or speak for those who have contracts which permit them to supply products they've developed.
As I understand it, many European nations permit the use of cannabis in different ways. I believe that Michelpro will be able to market the products it has rights to, just as Medmar has the rights inside the U.S.
It may very well be a fact that Europe will wait to see results of sales in the U.S. first. To my way of thinking, anecdotal evidence of effectiveness may be the best sort of publicity we can get in the immediate future.
If the psoriasis cream were a traditional drug, after the Phase 1 safety trial, I believe the next step would be a Phase 2 Trial for efficacy, which could be run in many different ways.
I believe it could be run in the open with all patients receiving the actual psoriasis cream, and success could routinely be observed in assessments of each patient. This could be the cheapest and quickest Phase 2, but it would almost certainly lead to a Phase 3 before approval.
The other extreme would be a small double blind study where some patients received the real cream, and others got a placebo cream, and after a specific number of patients were treated for a specified period of time the trial would be unblinded, and results could be reported. If the results were truly outstanding, approval should be possible in such a trial. If results were good, but didn't meet the level determined to be outstanding, an additional much larger Phase 3 Trial would be required that was largely done with the same protocol, but the requirement for approval would essentially be no higher than what was already observed, but just in a much larger body of patients.
I suppose the good news is that none of these trials are anything like the oncology trials which often take years of observations. I believe that the 60 day requirement in the safety trial is probably as much time as would be needed to judge efficacy.
On the other hand, if a similar approach is taken to MM, the trials could easily run into years like other oncology products. Once again, if the sublingual pills are available, more could be learned anecdotally before the trials even began.
It's my belief that OWCP doesn't want to speculate on what the people they have contracts with will do. If the contractor believes that they have all the evidence they need to begin sales in a given country, or state, they will do so without requiring permission from OWCP.
Gary
As I understand it, many European nations permit the use of cannabis in different ways. I believe that Michelpro will be able to market the products it has rights to, just as Medmar has the rights inside the U.S.
It may very well be a fact that Europe will wait to see results of sales in the U.S. first. To my way of thinking, anecdotal evidence of effectiveness may be the best sort of publicity we can get in the immediate future.
If the psoriasis cream were a traditional drug, after the Phase 1 safety trial, I believe the next step would be a Phase 2 Trial for efficacy, which could be run in many different ways.
I believe it could be run in the open with all patients receiving the actual psoriasis cream, and success could routinely be observed in assessments of each patient. This could be the cheapest and quickest Phase 2, but it would almost certainly lead to a Phase 3 before approval.
The other extreme would be a small double blind study where some patients received the real cream, and others got a placebo cream, and after a specific number of patients were treated for a specified period of time the trial would be unblinded, and results could be reported. If the results were truly outstanding, approval should be possible in such a trial. If results were good, but didn't meet the level determined to be outstanding, an additional much larger Phase 3 Trial would be required that was largely done with the same protocol, but the requirement for approval would essentially be no higher than what was already observed, but just in a much larger body of patients.
I suppose the good news is that none of these trials are anything like the oncology trials which often take years of observations. I believe that the 60 day requirement in the safety trial is probably as much time as would be needed to judge efficacy.
On the other hand, if a similar approach is taken to MM, the trials could easily run into years like other oncology products. Once again, if the sublingual pills are available, more could be learned anecdotally before the trials even began.
It's my belief that OWCP doesn't want to speculate on what the people they have contracts with will do. If the contractor believes that they have all the evidence they need to begin sales in a given country, or state, they will do so without requiring permission from OWCP.
Gary
