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It had long been known that the disease was associated with defects in the gastrointestinal tract: patients had chronic gastritis and lack of acid secretion (achlorhydria)

Two years later its confirmatory trial failed, and Amylyx pulled it from the market.In both cases, the agency changed its answer once enough pressure came from a drug company facing a deadline, or a patient group with a microphone.Drug company user fees have funded a large share of the FDA's drug review budget since 1992