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Alt immune Submits Investigational New Drug Application for NasoShield in Preparation for its Phase 1 Trial December 11, 2017 145 Patients to be enrolled Data expected in the second quarter of 2018
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Altimmune submits investigational new drug applications to the FDA for review.
Biopharmaceutical companies like Altimmune are required to file investigational new drug applications.
To fill out an investigational new drug application, companies must provide detailed information about the drug's safety and effectiveness.
The purpose of submitting an investigational new drug application is to seek FDA approval to conduct clinical trials.
Information on the drug's composition, manufacturing process, and proposed clinical trial protocol must be reported on the application.
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