Does anyone know about Israeli regulations. Once
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Posted On: 01/14/2019 7:42:59 PM
Does anyone know about Israeli regulations. Once proven safe in Phase 1, should the company be free to provide samples to appropriate Doctors while they're working to demonstrate efficacy in Phase 2.
Our FDA has made right to try a part of possible treatment, but I don't believe it would apply to drugs that have yet to demonstrate efficacy. Here I believe if the company wished to do it, they could sell the cream in legal cannabis stores, but they've determined they'll demonstrate efficacy first. What I'm saying is only true of State's where it's legal, Federally, it still isn't legal, but Justice is keeping hands off where it is legal according to State or Local regulations.
If the company is putting the cream in the hands of Doctor's in Israel who are not involved in the Phase 2 Trial, I would hope that if patients who try it want more, it could be sold to them, and if not, additional samples could be provided.
Of course there is another possibility, namely that the company is permitting any interested Dr. in Israel to participate in the Phase 2 Trial, without knowing the trial protocol, anything is possible. Frankly, knowing the cream was safe I'd love to hear that any dermatologist that wanted to participate could, the only requirement would be reporting back how the drug was used, and how well it did in that application. I'm suggesting it could be used on a variety of skin conditions, not just psoriasis. I don't know that this is possible, but it makes for an interesting discussion.
Gary
Our FDA has made right to try a part of possible treatment, but I don't believe it would apply to drugs that have yet to demonstrate efficacy. Here I believe if the company wished to do it, they could sell the cream in legal cannabis stores, but they've determined they'll demonstrate efficacy first. What I'm saying is only true of State's where it's legal, Federally, it still isn't legal, but Justice is keeping hands off where it is legal according to State or Local regulations.
If the company is putting the cream in the hands of Doctor's in Israel who are not involved in the Phase 2 Trial, I would hope that if patients who try it want more, it could be sold to them, and if not, additional samples could be provided.
Of course there is another possibility, namely that the company is permitting any interested Dr. in Israel to participate in the Phase 2 Trial, without knowing the trial protocol, anything is possible. Frankly, knowing the cream was safe I'd love to hear that any dermatologist that wanted to participate could, the only requirement would be reporting back how the drug was used, and how well it did in that application. I'm suggesting it could be used on a variety of skin conditions, not just psoriasis. I don't know that this is possible, but it makes for an interesting discussion.
Gary
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