Rethinking the penultimate event
At a time when FDA reform is in the air - the Clinton administration is poised to announce significant reforms and Congress will take up the issue in a few weeks - the workings of FDA advisory panels should also be on the table.
Advisory committee meetings are seminal events, often marking the defining moment in the perception of a company's science, its value and overall credibility.
A glance at the accompanying stock price charts reveals a typical course of a biotech company's fortunes in the regulatory review process: A build up of interest leading into the advisory panel meeting, with higher share prices reflecting optimism and anticipation of revenues upon agency approval, followed by a letdown as expectations are dashed (MedImmune) or a positive panel review becomes disassociated with the ultimate approval as time passes (Molecular Biosystems).
In mulling over whether advisory committees are