I know it seems hard to believe, but (IMHO) the existence of a patent will in no way encumber (and will actually help) the production, distribution, and adminis

I know it seems hard to believe, but (IMHO) the existence of a patent will in no way encumber (and will actually help) the production, distribution, and administration of this drug if it works. Entities that actually have expertise and capability in clinical development of such complicated biologics get through this process by burning billions of dollars. These billions are provided by investors who must have some reasonable chance at making a profit (or at least not losing a lot of money). Non-profit enterprises simply don't have the money or the expertise. The government has no expertise in the development path. The U.S. gov't (through the FDA) has vast amounts of expertise in analyzing clinical trial proposals and data, but not actually running them.