Replies to post #150940 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Accelerated approval allows the agency to approve drugs based on substitute measures of clinical benefit. For example, cancer drugs that cause tumors to shrink are considered likely to confer a meaningful clinical benefit, such as survival.

The same principal could be applied to drugs which appear to increase survival in a small number of people, Gottlieb said. It could be determined later whether benefit was statistically significant. -- Scott Gottlieb

NOTE: FDA draft guidance already provides AA can be given based on clinical evidence obtained from a meaningful number of sites - confirmation data can be provided AFTER this is granted.