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Posted On: 03/31/2017 2:13:41 AM
Post# of 15624
I believe I was right, and wrong, at the same time wrt efficacy trials. Here's a link to where they said they're running them:
http://www.prnewswire.com/news-releases/owc-p...31521.html
When I look in depth of what they're saying, it sound like they have a protocol that uses human psoriasis to try, but it doesn't appear to be on the people. It sounds like it's a protocol that's been accepted for trials, but I don't know that it would meet the criteria for approval as a drug.
This protocol, and completion of the safety trial on people, and I believe the company will meet its requirement for selling the cream as a cosmetic.
If they wanted approval as a drug, I believe a Phase 3 Trial or registrational Phase 2 would be needed for drug approval. Clearly that's not the direction the company is taking.
Gary
http://www.prnewswire.com/news-releases/owc-p...31521.html
When I look in depth of what they're saying, it sound like they have a protocol that uses human psoriasis to try, but it doesn't appear to be on the people. It sounds like it's a protocol that's been accepted for trials, but I don't know that it would meet the criteria for approval as a drug.
This protocol, and completion of the safety trial on people, and I believe the company will meet its requirement for selling the cream as a cosmetic.
If they wanted approval as a drug, I believe a Phase 3 Trial or registrational Phase 2 would be needed for drug approval. Clearly that's not the direction the company is taking.
Gary
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