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Biotech / Medical : Ionis Pharmaceuticals (IONS)

IONS 71.53

+2.4%

Nov 14 9:30 AM EST

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To: sds who wrote (2058)	6/30/1998 1:42:00 AM
From: Miljenko Zuanic	Read Replies (2) of 4676

Small correction on expedited versus fast-track terminology and meaning. Expedited review means that FDA will respond to application in six months, in contrast to regular NDA where they have to respond in 12 months. Quick FDA respond to famivirsen NDA was surprise for street (giving the electronic filling and FDA continuous and close trials follow actually it is not) and FDA want to clear this drug before it start to deal with three more important new HIV drugs: Sustiva, Abacavir and Amprenavir, which will all have fast-track status. Add to this that Novartis ordered (and pay) first Famivirsen quantity in April, FDA decision is not surprised at all. Fast-track is not only in connection to NDA review, it can be assigned to new drug in clinical development. It means that FDA can designate fast-track status for drug which is not yet in human trials (stupid example is ENMD endostatin/angiostation, but it is possibility and example), or for drug in any of the trials status if drug present/have potential to be break-trough treatment for any life-threatening disease. Miljenko

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