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Sarepta Therapeutics, Inc. Message Board

  • usagary1 usagary1 Jun 3, 2013 6:48 AM Flag

    Longs read this from friday afternoon ''Chris G

    May 31, 2013, 1:47pm EDT
    Sarepta’s meeting with FDA now expected later than first hoped
    Sarepta President and CEO Chris Garabedian said the $125 million stock offering is the largest in the company's history.
    Courtesy Sarepta

    Chris Garabedian, CEO, Sarepta Therapeutics

    Don Seiffert
    Associa Email

    One day after the CEO of Sarepta Therapeutics Inc. (Nasdaq:SRPT) told investors that a meeting to discuss accelerated approval of the biotech’s lead drug won’t happen until later than he’d hoped, he told Mass High Tech on Friday that it’s nevertheless “not a delay.”

    Chris Garabedian, CEO of the Cambridge, Mass. biotech, spoke on Thursday at the Deutsche Bank dbAccess Health Care Conference about eteplirsen, its drug aimed at the most common genetic mutation that causes Duchenne muscular dystrophy, or DMD.

    Sarepta is seeking accelerated approval from the U.S. Food and Drug Administration for the drug, and the company’s stock fell in mid-April after Garabedian said the FDA required some more documentation regarding that designation.

    Yesterday, it fell again when Garabedian said at the conference that “it looks like that the meeting that we were hoping to have calendered by the end of June... (will) be calendered in the third quarter based on (the FDA’s) checking with scheduling and also their need to take their time to review with teams internally.”

    But on Friday, Garabedian told Mass High Tech that there has never yet been a date confirmed by the FDA.

    “I wouldn’t call it a delay,” he said. “I was optimistically thinking that if (the FDA) was willing and able... that it would be by the end of the second quarter.”

    Sarepta has now submitted the requested documentation, and “they need a certain amount of time to revie

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