Extract to table

Because the study design required both co-primary endpoints to be met for the overall study to be considered positive, CLARION-3 must be classified as a failed confirmatory trial for purposes of the sNDA filing

During that meeting, the Division communicated several positions that are directly relevant to the current analysis: First, the Division stated that both co-primary endpoints in the confirmatory trial must be met in order for the confirmatory trial data to support the sNDA filing

This is a critical constraint on the analysis that follows: any regulatory path forward must account for the fact that FDA's stated standard — agreed to by both parties — was not achieved

However, the deferral is subject to an annual reporting obligation: Penterra must submit annual progress reports to FDA describing the status of the pediatric development program, regardless of whether the adult indication has been approved

Penterra must continue to submit these annual reports in a timely manner even during the dormancy period