Biopure Admits Its Blood Substitute Will Be Delayed

Updated from 7:42 p.m. EST

Biopure(BPUR Quote) admitted Thursday that problems with its human blood substitute Hemopure are forcing it to delay filing an approval application with U.S. drug regulators for at least six months.

TheStreet.com first reported late last month that a Hemopure delay was likely. Consultants hired by Biopure to assist with its pivotal clinical trial for Hemopure noted numerous, serious problems with data collection and analysis. In addition, TheStreet also reported that a Washington, D.C., law firm was crossing the country interviewing doctors involved with the Hemopure study.

Biopure executives had long maintained that Hemopure's filing would hit the doorsteps of the Food and Drug Administration by year-end. But late Thursday, the company acknowledged that the filing would not occur until the middle of 2002. ...