Replies to post #147641 on Biotech Values

[biotech jim]

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.

[wdr7]

It looks like their second study did not demonstrate benefits for mild disease patients.
"The EXPEDITION1 study did not meet co-primary cognitive and functional endpoints in the overall mild-to-moderate patient population; however, pre-specified secondary subgroup analyses in patients with mild Alzheimer's disease showed a statistically significant reduction in cognitive decline. Based on those results, Lilly modified the statistical analysis plan (SAP) for EXPEDITION2 prior to database lock to specify a single primary endpoint of cognition in the mild patient population. This revised primary endpoint did not achieve statistical significance."
http://finance.yahoo.com/news/eli-lilly-company-announces-top-110000601.html