I may be misunderstanding the Fed action, but I be
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Posted On: 12/27/2017 1:41:45 PM
I may be misunderstanding the Fed action, but I believe they simply won't police cannabis based industries and are leaving it up to the State's. State's which haven't legalized cannabis for either medical and/or recreational purposes will still police it's use.
I do believe that any cannabis based drug that had FDA approval would be available in all States, but we're years away from any of our products having FDA approval.
In some of the language used by the company in it's presentation it's clear they still want the U.S. market, I believe the real question may be, how badly do they want it. I believe if you really want U.S. approval, at least some of the drug trials you're doing need to be done in the U.S. and the clinical trials database should provide status for those trials. This of course would be far more expensive for them then trials in Israel, and they probably can wait and include the U.S. in Phase 3 Trials, but I doubt if they can gain approvals from the FDA without some of the trials being run here. I suspect the company will look to achieve initial approval elsewhere and then use some of the income from sales to go after U.S. approval.
I'm not suggesting their won't be sales here, their certainly will in State's where cannabis is permitted, but as good as I believe the cream will be, I doubt if it will legally be available in State's that don't permit cannabis by State laws until it has FDA approval.
The courts in a few cases have said that insurance companies needed to pay for cannabis based treatments in spite of the treatment not having drug approval, but I believe that was in State's where cannabis was legal. That argument might be extended to State's that don't have legal cannabis if patients sued for the rights to purchase and use the cream. The key is first demonstrating just how good the cream is, if it's that good, perhaps a shortcut will be found to FDA approval.
I'm no fan of the FDA, but I do happen to be on a drug, Gleevec, which the FDA actually expedited approval on many years ago because the evidence was so overwhelming. They can do it, but it's rare that they do.
Gary
I do believe that any cannabis based drug that had FDA approval would be available in all States, but we're years away from any of our products having FDA approval.
In some of the language used by the company in it's presentation it's clear they still want the U.S. market, I believe the real question may be, how badly do they want it. I believe if you really want U.S. approval, at least some of the drug trials you're doing need to be done in the U.S. and the clinical trials database should provide status for those trials. This of course would be far more expensive for them then trials in Israel, and they probably can wait and include the U.S. in Phase 3 Trials, but I doubt if they can gain approvals from the FDA without some of the trials being run here. I suspect the company will look to achieve initial approval elsewhere and then use some of the income from sales to go after U.S. approval.
I'm not suggesting their won't be sales here, their certainly will in State's where cannabis is permitted, but as good as I believe the cream will be, I doubt if it will legally be available in State's that don't permit cannabis by State laws until it has FDA approval.
The courts in a few cases have said that insurance companies needed to pay for cannabis based treatments in spite of the treatment not having drug approval, but I believe that was in State's where cannabis was legal. That argument might be extended to State's that don't have legal cannabis if patients sued for the rights to purchase and use the cream. The key is first demonstrating just how good the cream is, if it's that good, perhaps a shortcut will be found to FDA approval.
I'm no fan of the FDA, but I do happen to be on a drug, Gleevec, which the FDA actually expedited approval on many years ago because the evidence was so overwhelming. They can do it, but it's rare that they do.
Gary
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