Moxa, I agree that U.S. approval is the toughes
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Posted On: 07/26/2018 6:11:49 PM
Moxa,
I agree that U.S. approval is the toughest. What I would hope is that in places like Israel and Germany strong data in Phase 2 may result in an approval. I believe that the data need not be better than the medications taken internally because they have side effects that are unacceptable to many patients. I believe a topical cream with clear benefits and no or very minor side effects will be easily accepted in many places.
I don't know that Phase 2 Trials will be multinational, and if they are, I doubt if they'll be here in the U.S., but I believe they'll be sufficient to permit a Phase 3 to ultimately be done that includes U.S. participation. I still believe patent approval is as much a key as the trials, but once they're achieved, I suspect we'll see a big name partner who'll be willing to bring a Phase 3 Trial home.
Here in the U.S. it's not impossible to gain approval out of a Phase 2 Trial, but it's very rare. I think the added cost of doing the trial here, and delays it would probably cause, don't make it worth doing. Hopefully gain approval elsewhere, then expand it to the U.S. and other parts of the world. Likewise, they'll probably shoot for approval for psoriasis before serious trials are done on other skin diseases where benefits might even be greater. Once approved, nothing prevents Dermatologists or others from prescribing it for other conditions off label in countries where it's legal to prescribe, and available in drug stores, not just cannabis shops.
Gary
I agree that U.S. approval is the toughest. What I would hope is that in places like Israel and Germany strong data in Phase 2 may result in an approval. I believe that the data need not be better than the medications taken internally because they have side effects that are unacceptable to many patients. I believe a topical cream with clear benefits and no or very minor side effects will be easily accepted in many places.
I don't know that Phase 2 Trials will be multinational, and if they are, I doubt if they'll be here in the U.S., but I believe they'll be sufficient to permit a Phase 3 to ultimately be done that includes U.S. participation. I still believe patent approval is as much a key as the trials, but once they're achieved, I suspect we'll see a big name partner who'll be willing to bring a Phase 3 Trial home.
Here in the U.S. it's not impossible to gain approval out of a Phase 2 Trial, but it's very rare. I think the added cost of doing the trial here, and delays it would probably cause, don't make it worth doing. Hopefully gain approval elsewhere, then expand it to the U.S. and other parts of the world. Likewise, they'll probably shoot for approval for psoriasis before serious trials are done on other skin diseases where benefits might even be greater. Once approved, nothing prevents Dermatologists or others from prescribing it for other conditions off label in countries where it's legal to prescribe, and available in drug stores, not just cannabis shops.
Gary
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