Biotech Values

[iwfal]

existing FDA staffers will presumably have a lot of say in interpreting the provisions of 21st Century Cures that pertain to clinical-trial design.

Agree to a degree. Bureaucratic inertia and bureaucratic interpretation. For instance the FDA had done a reasonable job interpreting accelerated approval guidelines. But with a new commissioner, Woodcock, the Jenkins types jumping ship... it could get bad pretty fast.

Separately, it still amazes me how bad the Silicon Valley types are at biotech. High arrogance, but failing to understand that the order of complexity in the human body and the ratio of known to unknown is much worse than on a chip or in software and makes their methods unworkable. The quantitative difference makes a qualitative difference.