- Sarepta Therapeutics (SRPT) provides updates and color regarding eteplirsen on what seems to have been a generally well-received Q2 conference call.
- Investors should expect 96-week data in October.
- NDA is still expected for H1 2014.
- FDA will look at the totality of the data and could grant full approval (versus accelerated approval) based on robust clinical outcomes.
- Manufacturing scale up is proceeding — the company should be ready for commercial launch by the end of 2014. (webcast)
Sarepta talks eteplirsen, fields questions
Aug 8 2013, 09:17 ET