Steven Ayanov's questions to Alector Inc (ALEC) leadership • Q2 2025
Question
Steven Ayanov of TD Securities asked if the FDA specified a particular threshold for progranulin elevation or if only statistical significance was required. He also sought to confirm if the trial's 90% power to see a 40% slowing of disease progression was tied to progranulin levels.
Answer
CMO Giacomo Salvadore responded that the FDA did not specify a threshold for progranulin elevation. He reiterated that the power calculation for the clinical endpoint is analyzed separately from progranulin and remains unchanged. CEO Arnon Rosenthal added that a 25% slowdown in cognitive decline would be statistically significant and likely approvable.