The client asked the nearly impossible — a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it.
The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission within the next six months. So little time meant no room for hiccups, but there was a lot of history to overcome. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug, Premier Research was quickly immersed in more than 12 years of unfamiliar data. The client had not even asked the FDA for a pre-NDA meeting, a milestone that typically precedes the application by up to a year.
We took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.