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Gateway Biotechnology, Inc., a privately owned biotechnology company focused on drug products for the treatment of tinnitus and hearing disorders, received comments from FDA from a Type B Pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead program GW-TT2, a novel intranasally delivered drug product as a tinnitus therapy and received a positive response supporting the planned CMC, non-clinical and clinical development strategy. FDA also indicated that the 505(b)(2) NDA approval pathway is an acceptable approach for GW-TT2 drug development. Gateway Biotechnology, Inc plans to submit an Investigative New Drug Application (IND) to FDA in 2023 Tinnitus, often described as a ringing in the ears, afflicts nearly 15% of the population, yet there are no FDA-approved drugs currently on the market. The U.S. Centers for Disease Control estimates that over 50 million Americans experience tinnitus, with the majority of cases associated with noise-induced hearing loss. Roughly 20 million Americans struggle with burdensome chronic tinnitus, and among them, 2-3 million have extreme and debilitating cases sometimes associated with suicidal ideation. GW-TT2 is being developed as a therapy to provide immediate relief of tinnitus symptoms. "We are grateful to the FDA for their thoughtful feedback which provides a roadmap to opening an IND and initiating clinical studies”, notes Tom Brutnell, COO of Gateway. “This is an exciting time for Gateway as we lay the foundation for our proposed clinical studies that builds on years of preclinical work to address the molecular mechanisms underlying tinnitus”, notes CEO Jianxin Bao. “I'm grateful to the FDA and our employees, collaborators and CRO’s that have joined us on this journey to bring the first tinnitus drug to market.” “Tinnitus is the number one claim for disability for veterans," notes Philip Perez, co-founder of Gateway Biotechnology, Assistant Professor, University of Pittsburgh School of Medicine, Department of Otolaryngology, and Attending Surgeon at the Pittsburgh VA. “I am very excited about the work being conducted at Gateway Biotechnology which could positively impact the lives of millions of active duty and retired military service men and women.” About Gateway Biotechnology, Inc   Gateway Biotechnology is focused on the development of drugs to prevent and treat noise- induced hearing disorders and tinnitus. Our experienced team of preclinical and clinical professionals are dedicated to the development of novel therapies to help those suffering from hearing disorders. For more information, contact tbrutnell@gatewaybiotechnology or visit https://www.gatewaybiotechnology.com/ SOURCE Gateway Biotechnology, Inc.