Gilead GS-840 (adefovir dipivoxil) for HIV therapy on track for 1998 NDA, company tells Alex. Brown.
Executive Summary
GILEAD SCIENCES HOPING TO FILE 1998 NDA FOR HIV TREATMENT GS-840 (adefovir dipivoxil), Gilead Senior VP for Drug Development Howard Jaffe, MD, told an Alex. Brown analysts meeting in Baltimore. If a pivotal Phase II/III study underway "is positive, as we expect it to be, we anticipate filing an NDA in the first half of next year," Jaffe announced. The pivotal study, for which Gilead has completed accrual of 400 patients, will be completed this year, he said.