Auris Medical Receives Positive Scientific Advice from EMA on Development Plan and Regulatory Pathway for AM-111
Auris Medical Holding AG (EARS)
Last auris medical holding ag earnings: 8/10 06:31 am
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Source: GlobeNewswire
Design for single pivotal phase 3 trial validated by European Medicines Agency Regulatory pathway towards European market approval mapped out Strategy update scheduled together with earnings release for May 15, 2018 Zug, Switzerland, May 7, 2018 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, announced today that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the development plan and regulatory pathway for AM-111, its investigational treatment for acute inner ear hearing loss. The Scientific Advice (Protocol Assistance) had been requested by the Company following the results of the HEALOS phase 3 trial. The results showed, based on a post-hoc analysis, a clinically meaningful and nominally significant improvement in hearing for the AM-111
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