ARTICLE | Clinical News
Immupath pooled plasma: As part of a three-protocol Phase III trial
June 20, 1994 7:00 AM UTC
HEMA is scheduled to meet with the FDA on June 27 to discuss the company's plan to demonstrate the effectiveness of the method used to inactivate HIV in the donor material for the 400-patient protocol (CD4 counts of 50-200).
The third protocol for 200 patients having CD4 counts of 200-400 then will be resubmitted to the FDA with a modified end point of disease-free survival, or a 50 percent decrease in viral burden, or a 50 percent increase in CD4 counts. ...