Biotech Values

[steveporsche]

Here is a comprehensive white paper historical review of 135 FDA approvals of rare disease drugs. Given the number of drugs approved on "administrative flexibility" and "case by case flexibility", I would guess that a lot depends on which way the wind happens to be blowing on any given day in Bethesda, Maryland come review time. A number of these drugs were approved on pretty skimpy evidence a decade or two ago. I doubt that many of these drugs would be approved today on the same level of evidence.

http://rarediseases.org/docs/policy/NORDstudyofFDAapprovaloforphandrugs.pdf