"In addition throughout the SPA appeal, we have been aware of considerable outreach from physicians, investors, and industry groups to the FDA into elected representatives aimed at reinstatement of the ANCHOR SPA and approval of the ANCHOR sNDA.
We're thankful for this outreach and also thankful for the efforts of the many elected officials to ensure that this matter is seriously considered by regulatory authorities. We are certain that the FDA has considered not only the positive ANCHOR study results in this analysis. But also more recent data such genetic studies, which as Steve will discuss, add to our confidence and the positioning of REDUCE-IT to be successful." (Sept.16. CC)