On April 19, the FDA's Arthritis Advisory Committee discussed the fate of Aslera, Genelabs Technologies' (Redwood City, CA) synthetic dehydroepiandrosterone (DHEA) treatment for systemic lupus erythematosus. The meeting largely pits clinicians, who are keenly aware of the void of regulated therapies for lupus, against an FDA statistical review that repeatedly characterized Genelabs' data as “not statistically significant,” particularly for adverse events when compared with placebo. Despite this criticism, Genelabs' vice president of finance Matthew Loar argues that these were the first well-controlled studies in lupus, for which there has been a long-standing lack of consensus on how to judge efficacy (Nat. Biotechnol. 17, 319, 1999). In an unusual move, the FDA did not ask the Arthritis Advisory Committee to vote; without a formal recommendation, it promised to render its decision on DHEA, which has been granted orphan status, by June 26. DHEA has long been sold as an unregulated dietary supplement.