I believe that OWCP has been clear that they won't
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Posted On: 01/14/2018 11:32:15 PM
I believe that OWCP has been clear that they won't be selling any of the products they develop directly. They have established some collaborative agreements that keep their costs down, as well as provide for manufacturing commercial material for anyone acting to distribute and sell the products.
I know the costs will grow dramatically as they move into higher level trials, however if sales are initiated after Phase 1's end successfully, they should gain sufficient revenue to do the other trials even if those drugs aren't partnered. Of course the drugs being sold as cosmetics or nutraceuticals will have partners for at least those sales probably by Country or area of the world where they're being sold. The did cancel the agreement they had for the U.S. with Medmar, as I believe they determined they couldn't sell in all State's where it was legal. This reopens their ability to negotiate either on a State by State basis, or by someone who can cover all State's.
Their's a question on whether those with rights to sell products as cosmetics and nutraceuticals would also have the right to sell them once they're approved as drugs. The company's strategy may be keeping that separate so in time they could develop a relationship with big Pharma for drug sales.
I agree that ten years is longer than it will take to resolve these things, but while it could be much faster than that, drug approval often takes a decade of more when it comes to dealing with the FDA. In a Phase 3 Trial, it would not surprise me if the FDA required patient results to be observed over a period of a year of more, and a trial that require many hundreds to even a thousand or more to prove the drugs safe and effective.
Gary
I know the costs will grow dramatically as they move into higher level trials, however if sales are initiated after Phase 1's end successfully, they should gain sufficient revenue to do the other trials even if those drugs aren't partnered. Of course the drugs being sold as cosmetics or nutraceuticals will have partners for at least those sales probably by Country or area of the world where they're being sold. The did cancel the agreement they had for the U.S. with Medmar, as I believe they determined they couldn't sell in all State's where it was legal. This reopens their ability to negotiate either on a State by State basis, or by someone who can cover all State's.
Their's a question on whether those with rights to sell products as cosmetics and nutraceuticals would also have the right to sell them once they're approved as drugs. The company's strategy may be keeping that separate so in time they could develop a relationship with big Pharma for drug sales.
I agree that ten years is longer than it will take to resolve these things, but while it could be much faster than that, drug approval often takes a decade of more when it comes to dealing with the FDA. In a Phase 3 Trial, it would not surprise me if the FDA required patient results to be observed over a period of a year of more, and a trial that require many hundreds to even a thousand or more to prove the drugs safe and effective.
Gary
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