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.
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 ..