Immune Response Remune, Unimed NTZ cleared for expanded access by FDA.
Executive Summary
IMMUNE RESPONSE REMUNE EXPANDED ACCESS PROGRAM TO ADD 2,000 PATIENTS with CD4 cell counts under 300 or above 550, the company said Oct. 15. FDA authorized expanded access for the gp120-depleted inactivated "Salk" HIV-1 immunogen to individuals who cannot participate in the Phase III trial, which was limited to patients with CD4 cell counts between 300 and 550.