NorthWest Biotherapeutics Inc (NWBO)

[Poor Man -]

The staff at the FDA needs to get off their duffs.

The FDA is slow and subject to outside influences. There has to be a better way to manage drug approvals. NWBO appears to be a looming case study of how the FDA simultaneously deters investment in biotech and slows the treatment and prematurely kills patients by how they implement policy for drug approvals..

http://www.fdareview.org/05_harm.php

Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label drug uses in the United States with the on-label market. In the final section, before turning to reform options, we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits.