Novus Therapeutics Receives FDA Guidance on OP0201 Phase 2a Study in Patients with Chronic Otitis Media with Effusion
Study C-009 is designed to explore the effect of daily administration of OP0201 in patients with COME, a non-infectious form of otitis media. The study will enroll infants and children with three months or longer of bilateral middle ear effusion and hearing loss. The primary endpoints of study C-009 will be the resolution of middle ear effusion and/or restoration of hearing.
“We are pleased to have alignment with the
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