After Several FDA Setbacks, Idenix To Begin Clinical Study Of New HCV Nuc Outside The U.S.
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Idenix plans to bypass FDA’s IND process and initiate Phase I/II testing of IDX21437 in Canada and Belgium. It hopes those data will lead to combination testing of the nucleoside polymerase inhibitor with IDX719, its NS5A inhibitor, by 2014.