Extract to table

As set forth below, the extension is warranted by the scope and complexity of the matters raised in the Inquiry, the volume of materials and data that must be reviewed, and the steps Penterra has already taken voluntarily and in good faith to address OPDP's concerns

The extension is necessary, in the first instance, because of the substantial volume of promotional materials that Penterra must review in order to provide a comprehensive and accurate response

Because the Inquiry specifically references the sales representative detail aid bearing Material ID ZVR-2023-DA-007, Penterra has determined that it must investigate how its sales representatives communicated about Zelvara® in physician interactions where the detail aid was used or referenced

Through a preliminary review of distribution records, Penterra has identified fourteen (14) sales representatives in the Northeast region who received and distributed the detail aid at issue and whose customer-relationship management ("CRM") records, email communications, and text-message communications must be collected, preserved, and reviewed

The sales representative detail aid (Material ID: ZVR-2023-DA-007) has been recalled from field use; all sales representatives who received the detail aid have been notified by Penterra's Commercial Operations department that the material is no longer approved for use and must be returned or destroyed, and electronic versions of the detail aid have been removed from the sales force's tablet-based content management system