U.S. Bioscience regulatory update

The amendment includes UBS's response to questions raised by the FDA in December 1993, when the agency requested further analysis and an update of the completed pivotal trial in ovarian cancer. The trial included 242 patients, 121 of whom were accrued in the initial segment of the trial and the rest of whom were accrued following the FDA's request in 1992 for additional patient enrollment. New data, which are not being disclosed, are also included in the amended NDA. ...