Say Nay to Northfield

But turn the issue around -- what if Polyheme exacerbates injury or contributes to death in patients who already are severely injured?

Northfield designed an ambulance trauma trial for Polyheme because it wanted to see how the blood substitute performed in the real world, where all kinds of patients are bleeding to death from all sorts of accidents. After the fact, when the results aren't to its liking, the company can't go back and argue that Polyheme works, but only when conditions are perfect.

Lastly, if Northfield reduces the number of patients being analyzed due to protocol violations, it also should have to raise the statistical hurdle by which non-inferiority is measured. The company didn't do that.

My bet is that when the FDA does its own statistical analysis of the study -- and guaranteed, the regulators will do their own -- the results will look different from those issued by Northfield.

I've thrown a lot of numbers out here to make the case for why I don't believe Polyheme has a chance of getting approved, based on this current slug of clinical data. There are potentially other reasons, such as the overall safety of the product, which can't yet be addressed until Northfield releases complete data on the Polyheme trial, hopefully later this year.

In the meantime, Northfield will file Polyheme with the FDA and make its case for approval. There's nothing wrong with that. As an investor, however, it's better to sit on the sideline than get involved.