Client NDA Accepted for GIST Product
WALTHAM, Mass., February 12, 2020 – Conjugate Group, a flexible drug development service provider to the biopharma industry, is excited to announce that the FDA has accepted our client’s New Drug Application (NDA) and granted priority review for a novel treatment of patients with advanced gastrointestinal stromal tumors (GIST). A PDUFA date has been set, and we are optimistic that the treatment will be approved, bringing a new option to patients whose other treatment options have been exhausted.
Conjugate Group provided Medical Writing services to this client in a “rolling NDA” format, and integrated a functional team of multiple Medical Writers, QC Editors and a team lead to produce all clinical modules in the submission. This was complex study with many events, and our writers managed the task with tenacity and flexibility to deliver for the client under very tight deadlines. We are extremely proud to have played a small but critical role in the filing of this NDA, and owe our gratitude to the client and to the patients who participated in this study.
About The Conjugate Group
Founded in 2017, Conjugate Group provides flexible resources to clients in the biopharmaceutical industry, with a focus on the clinical development lifecycle. A leader in Consulting and Contract Services, we offer individual resources, full-function outsourcing, and milestone focused tactical teams to help our clients operate effectively and efficiently. We have helped numerous companies move products into and through the Clinic, from initial IND through registration and commercial launch.