Advanced Life Sciences reaches SPA agreement with FDA for Restanza Phase 3 study

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, and respiratory diseases, announced today that it has reached agreement with the United States Food and Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of its novel once-daily oral antibiotic Restanza to treat community acquired bacterial pneumonia (CABP). The trial is the first prospectively designed superiority study to be conducted in CABP.


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