[Correspondence] Nafithromycin in CABP: promise and precaution—authors’ reply

We thank Gupta et al. for their observations,1 however their comments suggest a certain unfamiliarity with the regulatory and scientific principles that underpin the design and approval of new antibacterial therapies such as those for community-acquired bacterial pneumonia (CABP), a condition largely treated empirically in out-patient settings. Unlike academic or investigator-initiated studies, pivotal trials are undertaken in consultation with regulators, and in this instance, the 12.5% non-inferiority margin and the choice of moxifloxacin as comparator were fully aligned with regulatory requirements.