Regulatory Conclusions
Provide data for spectrum of patients, particularly H.T.E. for first-in-class or promising next-in-class
Important to consider strength of NDA package
- one controlled, traditional study plus other well-designed studies in H.T.E. may be preferred over 2 identical studies in naïve and less rx experienced patients
Study designs must take into account targeted use-- H.T.E. vs. all patients