Regulatory Conclusions
Focus of today’s meeting is DRUG specific and not centered on regimens or management strategy
Contribution of a drug to safety and efficacy in broad pt populations as well as H.T.E. needs to be determined
Caveats about these trials
- need to know drug interactions up front
- dose selection is extremely important and may be different for H.T.E.
- baseline resistance testing is useful for construction of OBR and for outcome analysis