AB-PA01 product targeting P.aeruginosa infections
AmpliPhi Biosciences Corporation, a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced that the company has received positive feedback, via written response, from the U.S. Food and Drug Administration (FDA) regarding its development plans for AB-PA01, without the need for a Type B Pre-IND meeting … “We are delighted with the FDA’s response to our development plans for AB-PA01, AmpliPhi’s bacteriophage product candidate targeting Pseudomonas aeruginosa infections, and the FDA’s concurrence on the proposed design of two randomized controlled clinical trials, in hospital-acquired and ventilator-associated pneumonia and P. aeruginosabacteremia,” said Paul C. Grint, M.D., CEO … read more