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Will Sarepta Therapeutics’ Orphan Drug Eteplirsen Receive Accelerated Approval: TheStreet.com’s Perspective ?

December 10, 2012

       The question of whether or not Sarepta Therapeutics’ orphan drug Eteplirsen will receive accelerated approval for Duchenne Muscular Dystrophy (DMD) is a topic that has been analyzed and reviewed by multiple analysts over the past few months. 

       TheStreet.com’s December 10, 2012 article titled, “Sarepta Is Still A Buy: Recent Concerns Much Ado About Nothing” analyzes this question that has been chatted and buzzed about on the Internet. 

Upcoming Sarepta Therapeutics catalyst events :  

–  1st Quarter 2013 => Submission of briefing documents to FDA for an end-of-Phase II Meeting, including querying whether or not Eteplirsen is appropriate for Accelerated Approval  

–  2014 => A confirmatory study for Eteplirsen to start. 

References 

Motley Fool Blog December 10, 2012 article titled, “RNA Technology could save lives, create investment opportunity”

 Sarepta Therapeutics December 7, 2012 News Release titled, “Sarepta Therapeutics Announces a Continued Benefit on Walking Test Through 62 Weeks in Phase IIb …..” 

VermontToday.com December 10, 2012 article titled, “Mom seeks drug approval to help son”  

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

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