WSJ Article Comparing Sarepta (SRPT) and BioMarin (BMRN) 'Juvenile and Uninformed', Roth Capital Says
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Sarepta Therapeutics Announces Plans to Submit Rolling NDA for Eteplirsen following Today’s Pre-NDA Meeting with the FDA
May 19, 2015 4:00 PM EDT- Held pre-NDA meeting and agreed on rolling submission with the Agency -
- Will submit first two components of the NDA this week -
- Plans to complete the submission by mid-year -
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, for the... More
