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" ... There is a cost to this decision. The clinical trial for eteplirsen represents one of the smallest studies ever for a new drug, and it is has serious methodologic issues. (The biggest: Two patients who could not walk are excluded from many data analyses, and the study was conducted at one hospital, increasing the risk for bias.) Approving the drug without caveats could encourage drug companies to try to get drugs approved based on scant data by playing on patients’ emotions. ... "