BioMarin's Drisapersen 'Compete Response' Shows FDA Flexibility Still Limited
This article was originally published in The Pink Sheet Daily
FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.
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US FDA's Peripheral and Central Nervous System Drugs Advisory Committee to consider application, which PTC Therapeutics filed over protest.
Translarna’s best path forward is the file over protest pathway for the application, which received a refuse to file letter last year, PTC says; former OND Director John Jenkins calls it ‘a fairly rare event.’