>>What makes the drug business different from manufacturing in general is the much higher degree of government regulation at every stage of the process<<
If I understand your response correctly, you seem to be implying that the engineering and production of therapeutic proteins is highly predictable. Is the design and testing process also predictable? I'm not talking about the trials, although the early trials could affect the design process.
I don't want to oversimplify it, but if engineering (or reproducing, reverse engineering) these molecules is straightforward and predictable (except for the government influence), then our patented process and our expertise should certainly bear fruit on a continual basis going forward.