I’m surprised that only 16 people voted in a survey on such a high-profile program that addresses what is probably the greatest unmet need in medicine today. I surmise that there would have been considerably more interest in this survey if a small biotech firm rather than a Big Pharma owned the rights to the drug.
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.