Issues of clinical trial design are at the forefront in Alzheimer's drug development. Researchers and investors are weighing the impact of late-stage failures, even as significant unknowns remain about disease mechanism and the correlation of biochemical markers and clinical effects. A fundamental question hangs over AD drug development, which is unique in many respects: in deciding how to move from Phase II into Phase III, what can you know and how can you know it?

Eli Lilly has hedged its bets on its two late-stage Alzheimer's disease candidates. In a deal with TPG-Axon and Quintiles' partnering group NovaQuest, Lilly sheds risk (and potentially reward) in this notoriously difficult therapeutic space. A model for private equity / pharma deals going forward?

FDA is missing more new drug review deadlines: at least seven in the first eight months of this year. The experiences of those delayed applications indicate some interesting ways to interpret what it means when a user fee date comes and goes without an FDA decision. One clear observation: the longer a sponsor has to wait after the user fee deadline, the worse the likely result.