Polyphor Ltd., a clinical stage, privately held Swiss specialty pharma company focused on the development of macrocycle drugs addressing antibiotic resistance and respiratory diseases, today announced the receipt of a positive guidance from the end of phase II clinical meeting with the US Food and Drug Administration (FDA) for its leading product candidate, Murepavadin, for the treatment of patients with nosocomial pneumonia (Ventilator-associated and hospital-acquired pneumonia; VAP/ HAP).
The trial design, discussed in several interactions with the FDA, includes a 28-day mortality endpoint and a non-inferiority margin which corresponds to an overall trial size of less than 300 patients. It
The trial design, discussed in several interactions with the FDA, includes a 28-day mortality endpoint and a non-inferiority margin which corresponds to an overall trial size of less than 300 patients. It
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