"SALK" HIV-1 IMMUNOGEN MANUFACTURING, PROTOCOL CONCERNS RAISED BY FDA; AGENCY SEES NO SIGNIFICANT DIFFERENCE VERSUS PLACEBO FOR MOST SURROGATE MARKERS
Executive Summary
Immunization Products Limited's preliminary trials of the HIV-1 immunogen show few significant differences over placebo, according to FDA's reading of the data, Center for Biologics Evaluation & Research Senior Investigator Ira Berkower, MD/PhD, told FDA's Vaccines & Related Biological Products Advisory Committee at its Jan. 26 meeting.