Emily's questions to Alector Inc (ALEC) leadership • Q2 2025
Question
Emily from Stifel asked about the potential for regulatory approval if the INFRONT3 trial successfully meets its progranulin endpoint but shows more equivocal clinical data. She also asked for confirmation that the FDA remains aligned on the trial's sample size.
Answer
CMO Giacomo Salvadore stated that while the company is pursuing full approval, they would be open to dialogue with regulators based on the totality of evidence, citing the approval of tofersen in SOD1 ALS as a precedent for biomarker-based approvals. He also confirmed alignment with the FDA on the sample size following a 2023 blinded re-estimation.