Adaptive licensing is currently being promoted as a means for earlier patient access to novel drugs. However, there is a high level of uncertainty regarding the current regulatory feasibility of certain adaptive licensing strategies and the potential commercial advantages of such strategies. Daniel Lewinski and Christian Elze at Catenion explains the current EU and US regulatory frameworks and a methodology to assess the commercial implications of adaptive licensing strategies.
https://international-pharma.com/wp-content/uploads/2014/01/Adaptive.1.pdf