Just been having a quick trawl to see what i could dig up on a time frame for mipomersen to be approved in the EU from a few sites trawled apparently longer time frame of about 12 months for approval compared to FDA of about 10.5 months. There is a meeting from the approval discussion board CHMP who review the drugs this month around 16th June then the same in July so middle of the month we may hear something regards mipomersen. This will be a great catalyst I feel for antisense development lets hope it gets across the line in June. Does anyone have any thoughts on whether its easier in a sense to have new drugs approved in EU than by the FDA as I realise that you can have some that are approved in one but not the other anyway just a topic for discussion while we wait IMO patience required
eu timeframe for isis
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