I believe that OWCP's strategy is to market the cream essentially the same way that all sorts of body creams and lotions are marketed. I.E. they're going for FDA approval for safety, but not efficacy, so they cannot make the same sort of claims regarding efficacy that they could if they had efficacy trials labeling the product a drug.
As a drug, if truly curative, a one months supply might sell for hundreds, even thousands, but that's not the case if it's available like even the highest end normal skin products.
Don't get me wrong, I like the company's strategy and hope they're successful with it. Had they chosen to take the drug approach, the trial protocol they're using would be completely different. They would be required to treat patients with psoriasis in escalating dose trials until the optimum dose was determined, Phase I. Then they'd be asked to do a larger and longer Phase II Trial to demonstrate efficacy, and finally they'd be asked to do a much larger Phase III Trial which could take years, and after applying for approval the FDA could take six months or a year to determine if the drug was worthy. I.E. if they took the drug approach, it could be several years before the product could reach the market and the cost of the trials be in the hundreds of millions.
If the cream is truly curative for psoriasis it could certainly earn more than they're projecting, but at the same time it might replace the sales of billions of dollars currently spent on drugs for psoriasis. On the other hand, it may prove to have benefits, but not be curative, and then it would greatly improve the lives of those suffering with the disease, but wouldn't end the market for drugs. The key is, what happens when psoriasis patients start using the drug.
Gary
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