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Obstacle Thrown In Sarepta’s Path To Market As Gene Therapy Will Face AdComm After All

US FDA Looks To Probe Surrogate Endpoints

Executive Summary

The route to market for Sarepta’s gene therapy candidate SRP-9001 for Duchenne muscular dystrophy has just got more complex after a U-turn by the US FDA. Its accelerated approval will now be scrutinized by outside experts – but the company remains confident in its data.

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