If at first you don’t succeed, try and try again. And Biopure is trying and trying and trying.
The company is talking with the FDA to identify a patient population suitable enough for an upcoming study in patients with acute myelogenous leukemia (AML). Another go at the proverbial windmill or the final gasp of desperation from a company in trouble?
Given the shifting FDA standards, its unclear if Hemopure will ever get approved. Fake blood products were criticized in an article in JAMA back in April. Although, it should be noted that the “study” was co-authored by Public Citizen (and the normal conflicts of interest that come along with their involvement). The JAMA/Public Citizen “study” criticized the FDA for even allowing the products to be tested in people.
I first became acquainted with Biopure in 2000 or 2001 when I received a call from a broker at Salomon Smith Barney hyping the stock as the world’s greatest healthcare investment. The stock was trading near a $100 at the time. It’s currently trading at $0.50.
Biopure President and CEO Zafiris G Zafirelis (yes, that’s really his name) says: “We are very excited at the possibility of initiating a new clinical trial with Hemopure in the U.S.” Too bad shareholders don’t share his enthusiasm.
