Monday, January 31, 2000
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.