The Eteplirsen Precedent: No Denying It – So Let’s Define It
US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.
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The review manager most opposed to the eteplirsen approval offered his views of the process that led to the final decision and the 'circus' atmosphere of the advisory committee.
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