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


To: tom jones who wrote (2073)7/7/1998 11:11:00 PM
From: John Metcalf  Respond to of 4676
 
Tom, FDA committee meetings are open to the public, and are often reported in the press, when there is sufficient interest. Trading in a stock is usually halted during the Cmte meeting.

A vote or votes are taken at the meeting and reported, so you will know whether the committee finds Fomivirsen effective and safe. The FDA usually agrees with committee recommendations, but can take some time (measured in months) to resolve labeling issues and production issues.



To: tom jones who wrote (2073)7/16/1998 9:52:00 PM
From: DTselentis  Read Replies (1) | Respond to of 4676
 
Wasn't Isis's drug granted Priority Review by the FDA because it could be a great improvement over existing therapies ? Why would the FDA not want to approve a drug if no effective therapy exists. Its seems to me that if the drug can improve on existing therapies----even in a relatively small amount of patients the FDA would look toward approval.