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Summer Street released a note to clients Tuesday morning arguing Sarepta's
SRPT eteplirsen drug is unlikely to be approved under Subpart H accelerated approval given its 12-patient Phase 2 trial.
According to the firm, an FDA source recently cited a comparison of eteplirsen's dystrophin production to Vertex's
VRTX cystic fibrosis drug Kalydeco. Vertex's drug showed early dramatic sweat chloride reductions but still needed 2-48 week Phase 3 studies.
Sarepta shares are up 1.4 percent to $30.49 in mid-day action Tuesday.
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