ARTICLE | Regulation

Post-mortem on Immunex panel disclosure

January 31, 2000 8:00 AM UTC

GAITHERSBURG, Md. - The public's first opportunity to obtain briefing documents produced by FDA and a drug sponsor prior to an advisory committee meeting demonstrated that concerns raised by the agency before a meeting may not point to the outcome. Thus, although pre-meeting questions raised by the agency about study design, dosing and toxicity in Immunex Corp.'s application for Novantrone mitoxantrone were the subject of hours of debate, the Peripheral and Central Nervous System committee voted unanimously on Friday that the company had demonstrated efficacy in treating some forms of multiple sclerosis (MS).

Investors, who drove IMNX stock down $10.938 to $116.188 on Thursday after FDA posted the briefing documents on its website, may have to become more adept at reading between the lines to understand just how seriously they should take the issues raised by the agency for any given panel meeting. ...