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Isis Pharmaceuticals, Inc. Message Board

  • dinepat203 dinepat203 Dec 12, 2012 9:50 AM Flag

    Can anyone get the News from London on EMA meeting ?

    ISIS should receive European approval by year end. Remember this application addresses larger markets as they are seeking approval to treat both HoFN and HeFN, the latter being a much larger market opportunity.
    Following European approval we expect FDA approval on or before the PDUFA data of January 29th. ISIS is a buy under $12.

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    • Isis California facility gains GMP certification from EMA | Global News ...
      9 Oct 2012 – “The European regulatory approval of our manufacturing facility is an important milestone for Isis and a validation of our high standards and ..

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