Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology. We conduct clinical trials to assess the safety and efficacy of our investigational drugs. The establishment of the safety and efficacy of these drug candidates helps us obtain approvals from regulatory agencies such as the FDA, which approvals are required before these drug candidates can be made generally available to patients. We encourage awareness of and participation in our clinical trials and believe that participating in clinical trials is the best way for patients to access investigational drugs prior to regulatory approval.
At this time, we do not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval. Individuals interested in participating in clinical trials for our products may visit the “Pipeline” section of our website for information on our ongoing clinical trials. We will update this page as we grow and reassess our approach to expanded access programs. If you have any questions, please contact email@example.com.”
Otonomy may revise this expanded access policy at any time. Additionally, the posting of this policy by Otonomy shall not serve as a guarantee of access to any specific investigational drug by any individual patient.