ARTICLE | Regulation


June 21, 1993 7:00 AM UTC

The brutal treatment Vestar Inc.'s DaunoXome received at the hands of an FDA advisory panel last week should provide a stiff poke in the ribs to any biotech executive who isn't building an end-game strategy for product approval.

Many of the failures we've witnessed in the past two years - in sepsis, wound healing, and now in AIDS patients with Kaposi's sarcoma - are in complex, multifactorial diseases where appropriate end points may be difficult to define. Nevertheless, companies have an obligation to demonstrate such meticulous rigor in the product development process that failure, if it occurs, will not be blamed on management. Because if investors conclude the industry is packed with bumbling amateurs, the money will never come back to the sector. ...