The Company and the U.S. Food and Drug Administrat
Post# of 72440
Quote:
The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting concerning the continuing development of Brilacidin oral rinse to decrease the incidence of severe OM in HNC patients receiving chemoradiation. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on severe OM when cisplatin, the preferred chemotherapy regimen in HNC care, is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.
Quote:
The Company continues to build upon its recent productive End-of-Phase 2 meeting with the FDA through ongoing interaction with the European Medicines Agency (EMA). The first stage of review by the EMA regarding the Company’s application for Scientific Advice was recently completed. The Company looks forward to advancing its planned Phase 3 clinical development for the Brilacidin oral rinse program, in both the United States and Europe.
I tell ya, people just need to have patience imo. I'm thinking we'll see the subsidiary moving forward with this soon enough. In what way and how big is what I'm waiting to see. And with whom at the helm.