had “ benefitted enormously ” from patients’ input.... But she added that the problems with Amylyx’s

WASHINGTON— When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval?... That’s the question behind many of the Food and Drug Administration’s toughest decisions, including last year’s controversial approval of Aduhelm.... But after months of intense lobbying by ALS patients and their representatives in Congress, the agency said it could submit the drug based on the smaller study....