James Hatfield, PhD., director of clinical research at Cubist Pharmaceuticals has reportedly forgotten which test group was given a placebo in their phase III clinical trial of Ceftolozane, the firm's flagship antimicrobial B-lactamase inhibitor. "Shit, I know I wrote this down somewhere," muttered an exasperated Hatfield. "Goddammit," he added.
Ceftolozane, a potent antibiotic which showed significant promise in combating multidrug-resistant gram-negative bacterial infections, began phase III clinical trials in 2013. In June of 2014, Cubist had submitted a New Drug Application (NDA) to the US Food and Drug Administration.
After exceptional results from the phase III trials, Ceftolozane seemed poised to enter the US market in late 2014; however, doubt has been cast on the clinical data after recent revelations that the double blind experiment had unintentionally become triple blind.
"I mean, it sort of looks like Group A was given the active drug from these clinical reports," stated Hatfield, intently staring at one of two sets of clinical data. "Really, I've got a fifty-fifty shot at being right here."
As of press time Dr. Hatfield was reportedly overheard saying "eeny, meeny, miny, moe" from inside his locked office.