Author : adminDate : 2019-10-25 00:00

HLB completes Pre-NDA meeting with FDA

HLB announced that the Elevar Therapeutics has completed a pre-NDA meeting with the FDA.

The meeting proceeded with representatives of FDA Center for Drug Evaluation and Research (CDER) from the Office of Hematology and Oncology Products (OHOP), the Office of Clinical Pharmacology (OCP), and the Office of Biostatistics (OB) along with Alex Kim (CEO of Elevar Therapeutics) and representatives of clinical trials and CMC. Alex Kim said, “We will continue to discuss with consultants based on the content of discussion with the FDA.”

In the meantime, FDA must send the meeting minutes to Elevar Therapeutics within a month.