Biopure May Not Reach FDA This Year

Biotech firm Biopure (BPUR Quote) is telling institutional investors privately that an approval application for its experimental blood substitute will likely be delayed until early next year, according to a fund manager briefed by the company.

This doesn't match what executives of the Massachusetts-based firm have said publicly. As late as last month, CEO Carl Rausch told attendees at an investment banking conference that the regulatory filing for Hemopure would reach the doors of the Food and Drug Administration by the end of the year.

A delay would be a setback for Biopure and a disappointment for the company's investors. Filing delays are not uncommon for companies, however, given the complexity of drug applications. One fund manager tells TheStreet.com that Biopure executives told him last month that the odds are very good there will be a delay of up to three months, while assuring him the reasons for the late filing are relatively benign delays with finishing touches. ...