Edition:
United Kingdom

Auris Medical Receives FDA Guidance At Type C Meeting For AM-111


Thursday, 30 Aug 2018 

Aug 30 (Reuters) - Auris Medical Holding AG ::AURIS MEDICAL RECEIVES FDA GUIDANCE AT TYPE C MEETING FOR AM-111 IN THE TREATMENT OF SUDDEN SENSORINEURAL HEARING LOSS.AURIS MEDICAL HOLDING AG - TYPE C MEETING HAD BEEN REQUESTED BY COMPANY FOLLOWING RESULTS OF HEALOS PHASE 3 TRIAL.AURIS MEDICAL - FDA REVIEWED PROPOSED CONCEPT FOR PIVOTAL TRIAL WITH AM-111 0.4 MG/ML IN PATIENTS SUFFERING FROM ACUTE PROFOUND HEARING LOSS.AURIS MEDICAL HOLDING AG - IN TRIAL FOR AM-111 FDA PROVIDED GUIDANCE ON REGULATORY PATH FORWARD.AURIS MEDICAL - IN WRITTEN RESPONSE FDA ENDORSED CHOICE OF AM-111 PRIMARY, SECONDARY ENDPOINTS, SAFETY ENDPOINTS, AMONG OTHERS. 

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