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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?


To: sds who wrote (1922)4/9/1998 8:20:00 PM
From: marc ultra  Respond to of 4676
 
sds: thanks, I'll defer to your superior knowledge of the FDA and your reasonable points. I wonder if we're going to sit on dead money now until some more news comes out on 2302 one way or the other

Marc



To: sds who wrote (1922)4/9/1998 10:51:00 PM
From: ewolf  Read Replies (1) | Respond to of 4676
 
Listened to the company's conference call. Their view is that the drug can be approved before the end of the year. They have not applied for fast track status but they believe that the fda has indicated that they are on the same time frame as fast track. Fomivirsen seems to be the superior drug for cmv by a wide margin. Isis thinks that cmv will occur more frequently in the furture and the drug may have a significant enough market. Regardless, they get milestone payments and other support from Ciba. Also said that the issue with the fda of antisense technology is basically behind the company. Isis has had an ongoing dialogue with the fda during the development of the drug which has been useful for the company. The fda understands the technology according to Isis. Isis may not become a major pharmaceutical overnight but their potential seems stronger than ever if one can view them apart from the price of their stock.



To: sds who wrote (1922)4/10/1998 12:46:00 AM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 4676
 
sds:

I agree with ewolf that Fomivirsen can be reviewed by FDA in relative short time. From three NDA review categories: regular, expedited and fast track review, fomivirsen should feet somewhere between regular and expedited.

It was true that FDA was on Isis back for past few years, so they do know well not only Fomivirsen,, but 2302,...Also, depend how busy is antiviral dept. at FDA. Add that Isis submitted large part of NDA file electronically (maybe first one?), review should not take that long. But, who knows FDA and their status?

Anyway, in next 12 months real story (or more accurate) about CMV retinitis will be available and with this Fomivirsen near term revenue potential.

mz