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Re: DewDiligence post# 150810

Wednesday, 12/12/2012 8:57:57 AM

Wednesday, December 12, 2012 8:57:57 AM

Post# of 253591
LLY will run another phase-3 Solanezumab study in mild AD before considering whether to submit an BLA:

http://finance.yahoo.com/news/lilly-provides-next-steps-solanezumab-115500057.html

Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase 3 study of solanezumab in patients with mild Alzheimer's disease. Additional details, including study design and length, are still being determined. Lilly expects to initiate this study no later than Q3 2013.

Based on recent meetings with the U.S. Food and Drug Administration (FDA), Lilly does not intend to submit a Biologics License Application (BLA) at this time in the U.S. based solely on the existing analyses of data from the EXPEDITION studies.

This is hardly a surprise to most of the participants in a recent iHub survey, whose results were reported in #msg-80638500.

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