Say Nay to Northfield

I disagree. I believe the chances of the FDA approving Polyheme -- based on the data available -- are infinitesimally slim.

I don't blame Northfield for trying. After all, Polyheme is all the company has on its plate. But I've received email from some investors asking me if taking a bet on beaten-down Northfield is a good one. It's a $4 stock, they write, so what is there to lose?

My response: You'll lose everything. Don't do it. Let me explain why.

A Look Back

First, however, some background. Northfield's ambitious phase III trial evaluated the efficacy and safety of Polyheme in patients suffering from trauma. The study randomized 712 badly bleeding patients into two groups -- 349 patients received Polyheme in an ambulance on the way to the hospital, while 363 patients received currently used therapy, which is saline in the ambulance and then blood, if needed, upon arrival at the hospital.

The study's primary endpoint was designed to determine whether Polyheme was better than or non-inferior to (not worse than), the standard treatment. This was measured by comparing the death rates in each arm of the study, measured 30 days after the accident.

According to Northfield, 46 patients in the Polyheme arm died -- a death rate of 13.2%. Thirty-five patients in the control arm died, for a death rate of 9.6%. Obviously, Polyheme wasn't superior to blood and saline, but was it non-inferior? When Northfield ran the statistical test on these death rates, it missed.