BioCentury
ARTICLE | Clinical News

HML's Hemolink delayed in U.S.

August 13, 2001 7:00 AM UTC

Hemosol (TSE:HML) said Monday that the company will not restart a U.S. Phase III trial of its Hemolink blood substitute within the next 6 weeks as planned. The announcement follows a verbal communication from the FDA, in which the agency said it will not accept protocol amendments the company submitted earlier this year for a Phase III trial to reduce use of donor blood in coronary artery bypass graft surgery ( CABG) (see BioCentury, June 4). ...