Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decisi
A meeting of the Data Monitoring Committee (DMC) for Studies GS-US-321-0105 and GS-US-321- 0106 was held on 28 October 2016 to review the results of the Week 96 interim analysis. The primary efficacy analyses were not statistically significant for either of these non-alcoholic steatohepatitis (NASH) studies. Based on the recommendation of the DMC, Gilead has opted to terminate the NASH studies due to lack of efficacy.
