Ionis Pharmaceuticals (IONS) Message Board

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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: Perry who wrote (2054)	6/29/1998 12:19:00 PM
From: sds	Read Replies (3) of 4676

Perry, here's a (very) brief explanation of the difference... Expedited review really doesn't mean a whole lot. It basically means that the filer (the company) had their *&%^ together and was able to submit all of the data in a very organized and timely format. It can also indicate that the FDA thinks the drug is valuable vis a vis present treatments. Fast-track review is a fundamentally different animal. Fast-track review is primarily for drugs that treat life-threatening ailments for which there are few (or no) good therapies. It is a comprehensive "program" whereby the company can get through trials faster and can get approval with less data than would otherwise be possible. I realize this is a very elementary explanation, but I think it should suffice. Summary? Expedited = good paperwork, the company behaved and the FDA wants to reward them. Fast Track = A potentially very significant drug and a situation where the FDA is willing to go out on a limb to see the drug approved and marketed. Scott, I too read that article on the increased side-effects in AIDS cocktail patients. I haven't read anything about CMV, though. While I may be reading the pieces too literally, they seem to talk mostly about "new" side-effects. I hope I'm wrong -- anything that builds the CMV market will help Isis. Any news on when/if Isis could try Formavirsen for other CMV-related diseases? Given the rather fragile nature of antisense strands, perhaps they can't employ it in other CMV illnesses.... sds

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