ALS Drugs: FDA Panel Weighed Less-Than-Ideal Data Against Amylyx’s Ability To Set Postapproval Price

National Institute on Aging’s Brian Traynor questioned whether Amylyx would seek to recoup its money on AMX0035 in 2-3 years, before the Phase III PHOENIX trial completes, or whether pricing would be based on long-term market expectations. NINDS’ Kenneth Fischbeck said Amylyx should reopen US sites in Phase III trial and broaden expanded access instead of seeking approval now.