TLR-AD1 / NovAccess Global - LARVOL DELTA

NovAccess Global Receives FDA Approval of Orphan Drug Application for TLR-AD1 (Issuer Direct) - "NovAccess Global...announced the approval of its application with the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation (ODD) for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma and other high-grade gliomas. 'Orphan Drug Designation is yet another timely milestone achieved by NovAccess Global as we prepare an Investigative New Drug (IND) application for FDA approval to start human clinical trials. We expect to submit the IND in the first half of 2023'..."

IND • Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

NovAccess Global Announces Filing of Orphan Drug Application for TLR-AD1 (Issuer Direct) - "NovAccess Global...announced the filing of an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma multiforme (GBM) and other high grade gliomas....'Receiving this important designation would represent a milestone in the development of TLR-AD1 and would highlight the need for potential new treatment options for patients with aggressive brain cancers which today have no immunotherapy treatment leaving only the option of highly invasive and complicated surgery'."

Orphan drug