» Sarepta Therapeutics announce plans to submit rolling NDA for eteplirsen Action Duchenne

» Sarepta Therapeutics announce plans to submit rolling NDA for eteplirsen Action Duchenne: "Sarepta Therapeutics, Inc. announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding eteplirsen. Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical: chemistry, manufacturing and controls components of the NDA by the end of this week. As previously announced, Sarepta plans to submit the final component of the NDA by mid-year 2015.
“We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA,” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “The initiation of our NDA submission for eteplirsen marks a significant milestone for the Duchenne community and we look forward to completing the submission by the middle of the year and to continuing to work with the Agency towards the goal of providing treatments to patients as quickly as possible.”
You can read the full press release from Sarepta by opening the document below:"



'via Blog this'