Seeking Alpha

Sarepta's Garabedian gives eteplirsen update

  • Sarepta Therapeutics' (SRPT) CEO Chris Garabedian updates investors on eteplirsen at the Morgan Stanley healthcare conference.
  • Garabedian isn't impressed with Prosensa (RNA) and GlaxoSmithKline's (GSK) DEMAND-2 study — the bar for assessing dystrophin production was "low," he says. (More on drisapersen here)
  • SRPT will meet with the FDA in October to discuss chemistry, manufacturing and controls requirements for the planned NDA. The planned H1 2014 FDA filing depends upon whether the regulator shows a "reasonable amount of flexibility" regarding the requirements.
  • The company will take new samples in order to give the FDA additional dystrophin production data to work with.
  • More here from Adam Feuerstein.
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