Please correct me if I'm wrong. I believe if the
Post# of 15624
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Posted On: 02/27/2019 9:23:23 PM
Please correct me if I'm wrong. I believe if the company gained FDA approval it could be sold in every State or territory under U.S. control and many countries would approve it as well based on the U.S. FDA approval. That said, the company continues to say that at some point they'll have product on sales where cannabis sales are legal.
I believe the company is still stating that not every product will need full FDA drug approval before reaching store shelves. Rather I believe they want to at least test products until both safety and a degree of efficacy is observed. There is absolutely no reason to do the most expensive Phase 3 Trial for a product which shows little or no efficacy in a Phase 2 Trial, so the furthiest they need to take products before putting them on shelves where cannabis is legal Phase 2. In fact, if the initial trial was being done with patients with the disease being treated, a case could probably be made for marketing them after a well designed Phase 1/2.
Please tell me if I'm wrong, that the FDA can approve a drug and it still can't be sold everywhere in the U.S. If that is true, I'll stop my belief the company in it's own language is still saying we're taking a two pronged approach.
Gary
I believe the company is still stating that not every product will need full FDA drug approval before reaching store shelves. Rather I believe they want to at least test products until both safety and a degree of efficacy is observed. There is absolutely no reason to do the most expensive Phase 3 Trial for a product which shows little or no efficacy in a Phase 2 Trial, so the furthiest they need to take products before putting them on shelves where cannabis is legal Phase 2. In fact, if the initial trial was being done with patients with the disease being treated, a case could probably be made for marketing them after a well designed Phase 1/2.
Please tell me if I'm wrong, that the FDA can approve a drug and it still can't be sold everywhere in the U.S. If that is true, I'll stop my belief the company in it's own language is still saying we're taking a two pronged approach.
Gary
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