OWCP needs to clarify their intentions regarding their various contractors based on the language in the 10-K.
To me, their seems to be a conflict between Emilia and Medmar with regard to who will make the psoriasis cream, and when. I certainly may be confused, but in one case it seems that Emilia has rights, and perhaps that's the case once full FDA Approval is in place, but Medmar may market it in State's where medical marijuana is legal until then. I'm not saying this is the case, I'm saying I'm confused and would like to see clarification of what their intention actually is.
Likewise, the language regarding the Feds in places sounds like full FDA Approval is needed, but they speak of sales later this year. Their is no doubt about the fact that the safety trial can be concluded, probably before July, but efficacy trials are a very different matter. Efficacy trials, depending on FDA requirements, could take a few years, but even if the protocol was something that could be completed in a few months would take over a year when you allow three months for the review of the IND, some time for the IRB to finalize the protocol, lets say two months. I believe that four months would be the bare bones minimum time to actually run the trial and submit results, but I suspect it would be substantially longer, including time to prepare a NDA for submission to the FDA. The FDA then gets at least 6 months for a priority review, or a year if not deemed priority, to act on the NDA. My point is, if efficacy trials are to be done to the FDA standards, at least 15 months will be needed, but it's much more likely that it will take two years or more.
I believe what's needed is a clear understanding of how they intend to proceed, and I suspect it would be something like this:
Medmar will have the rights to market products proven safe to the FDA in State's where medical marijuana is approved.
On the approval of the FDA and other govt. agencies of efficacy, Emilia will be permitted to market the cream in all countries who've approved the drug. Depending on the approving agency, the cream would either be available over the counter, or by prescription only. Once full FDA approval is granted, the cream would not be restricted to medical marijuana states, as it would have full approval as a drug. Medmar should be able to continue it's sale at Green Cross stores if they choose, but elsewhere it would be sold through the Emelia contract.
Please feel free to correct anything I'm saying, I'm saying that I'm confused about this and if someone knows I'm wrong, please try to clarify how this is to work.
Gary
To me, their seems to be a conflict between Emilia and Medmar with regard to who will make the psoriasis cream, and when. I certainly may be confused, but in one case it seems that Emilia has rights, and perhaps that's the case once full FDA Approval is in place, but Medmar may market it in State's where medical marijuana is legal until then. I'm not saying this is the case, I'm saying I'm confused and would like to see clarification of what their intention actually is.
Likewise, the language regarding the Feds in places sounds like full FDA Approval is needed, but they speak of sales later this year. Their is no doubt about the fact that the safety trial can be concluded, probably before July, but efficacy trials are a very different matter. Efficacy trials, depending on FDA requirements, could take a few years, but even if the protocol was something that could be completed in a few months would take over a year when you allow three months for the review of the IND, some time for the IRB to finalize the protocol, lets say two months. I believe that four months would be the bare bones minimum time to actually run the trial and submit results, but I suspect it would be substantially longer, including time to prepare a NDA for submission to the FDA. The FDA then gets at least 6 months for a priority review, or a year if not deemed priority, to act on the NDA. My point is, if efficacy trials are to be done to the FDA standards, at least 15 months will be needed, but it's much more likely that it will take two years or more.
I believe what's needed is a clear understanding of how they intend to proceed, and I suspect it would be something like this:
Medmar will have the rights to market products proven safe to the FDA in State's where medical marijuana is approved.
On the approval of the FDA and other govt. agencies of efficacy, Emilia will be permitted to market the cream in all countries who've approved the drug. Depending on the approving agency, the cream would either be available over the counter, or by prescription only. Once full FDA approval is granted, the cream would not be restricted to medical marijuana states, as it would have full approval as a drug. Medmar should be able to continue it's sale at Green Cross stores if they choose, but elsewhere it would be sold through the Emelia contract.
Please feel free to correct anything I'm saying, I'm saying that I'm confused about this and if someone knows I'm wrong, please try to clarify how this is to work.
Gary
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