From what I understand, they are seeking approval for only some very specific type of condition and the 'last resort' treatments, not a general use of the drug. This will eliminate a lot toxicology issues and large trial requirements.
They have been working with FDA to ensure that all the approval requirements are addressed upfront in order to gain certainty in obtaining approval.
I won't be surprised if the approval will be forth coming earlier as a lot of preapproval work has been done over the last 7 months
eu timeframe for isis, page-2
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