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" ... The data available for Sarepta's new drug, golodirsen, shows that it increases dystrophin to 1.2% of what would be found in a normal patient. That's an 11-fold increase over what is found in muscular dystrophy patients, Sarepta says, and more than triple the amount found with Exondys. (The two drugs target different genetic mutations that can cause Duchenne, and therefore different groups of patients.) Would the FDA stand by the standard of offering early approval to muscular dystrophy drugs based only on the production of this protein in muscle, without other evidence that they make patients more mobile, stronger, or healthier? ... "