LIGHT Data Release Raises Heavy Issues for Small Sponsors
This article was originally published in RPM Report
Executive Summary
It was supposed to be good news: Orexigen announced a new patent for its weight loss drug Contrave, supported by strong CV safety data from the interim analysis of LIGHT. The controversy that followed underscores how hard it will be for small sponsors to satisfy FDA in the future when it comes to protecting interim data from long term outcomes trials.