Full FDA approval had been delayed pending regulatory review of additional clinical data.

FORBES: AstraZeneca's Big Green Light

Complicating matters for Merck and Schering is the fact that the companies delayed the release of the ENHANCE trial data by more than a year, releasing it only after inquiries from Forbes.

FORBES: Magazine Article

The drug had been delayed as the U.S. Food and Drug Administration asked for more data.

FORBES: With Drug Approval, Lilly Sighs Relief

As I was first to report in 2007, Merck and then-partner Schering-Plough delayed analyzing the study, called ENHANCE, for months over what they believed were data quality problems.

FORBES: Merck To Pay $688 Million To Shareholders For Delaying Vytorin Results

Schering-Plough and Merck say the ENHANCE trial is delayed because some of the images produced are "biologically implausible, " requiring laborious rechecking of data.

FORBES: Magazine Article