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Sarepta Therapeutics’ Orphan Drug Eteplirsen And FDA Accelerated Approval

December 28, 2012

Recent Internet buzz on whether or not Sarepta Therapeutics’ orphan drug Eteplirsen for Duchenne Muscular Dystrophy is to receive FDA accelerated approval :

1) The Motley Fool December 24, 2012 article titled, “2 New Growth Catalysts Could Send This Stock Higher”

2)  GlobalRegulatoryScience.com article titled, “Will Sarepta Receive Accelerated Approval ?”

3)  Muscular Dystrophy Association’s December 27, 2012 article titled, “MD Briefs: Gene Therapy, Exon Skipping, Stem Cells”

Upcoming Catalysts

  1. To present Company Overview on January 9, 2013, at the JP Morgan Global Healthcare Conference. Chris Garabedian, Sarepta’s President and CEO, will be the presenter. The presentation will be webcast live under the events section of Sarepta Therapeutics’ website
  2. Plans to ask for a meeting with the FDA for scheduling a meeting for the 1st Quarter of 2013 to discuss asking for Accelerated Approval for Eteplirsen and to also discuss a Phase III clinical trial for Eteplirsen
  3. Investors probably will not be hearing about the results of the FDA meeting until about March – April 2013
  4. Plans are for a future meeting with the FDA about the chemistry, manufacturing, and controls (CMC)
  5. 74-week Eteplirsen clinical trial data.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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