Hemosol Inc. regulatory update

The FDA and Canada's Health Protection Branch said they will require additional information before approving human clinical studies of the Toronto company's Hemolink product, a hemoglobin-based oxygen carrier under development as a blood substitute. Hemosol said it believes the FDA's questions arise from differences of scientific interpretation of preclinical data. The HPB's concerns are related to a pre-screening test to be used for human volunteers prior to the Phase I study, the company said. Hemosol said the pre-screening test was put in place to reduce the risk of receiving contaminated blood. ...