Pooled secondary analyses do not a regulatory success make
Obviously.
LLY has been a pioneer in stating they may need to go to earlier treatment efforts in this patient population. May need some patent law reform for such drugs due to the time-consuming path of development. The beta amyloid hypothesis may not be dead after all.
Would be interersting to hear the deliberations with the agency on next steps, and to hear the deliberations within the agency as well.
Congrats to LLY and to all the efforts of the investigators and patients.