Transcript:

If you read the, you'll realize that there is very little support for Polyheme or any first-generation blood sub because of serious questions about safety. That includes situations where patients are at risk for death due to the unavailability of blood. [Polyheme, by the way, has never been studied in such a situation.
Take special note of comments made by Dr. Tom Fleming, a noted bio-statistician, who completely dismantles Northfield's argument for using a "per protocol" analysis of the Polyheme data as a truer gauge of the blood sub's efficacy and safety. Fleming's comments can be found in the transcript of the April 29 meeting, starting on page 292.
The FDA is likely to hold an advisory committee meeting to discuss and review the Polyheme application before the April 30 decision date nears. My bet: The meeting will not go well for Northfield, which will give FDA all the public ammunition it needs to reject Polyheme. [Not that the agency really needs any new reasons to reject Polyheme, but a rebuke from an advisory committee will make it easier.]
One more note to seal Polyheme's fate: Dr. Sydney Wolfe is listed as a co-author on Natanson's JAMA paper regarding the safety risks of blood substitutes. Wolfe works for Public Citizen and is an outspoken critic of drug safety. More important, the FDA recently appointed Wolfe a permanent member of the FDA Drug Safety and Risk Management Committee. This FDA drug safety committee is certain to get involved in the Polyheme review. As the co-author of a paper that concludes blood subs, including Polyheme, to be unsafe, Wolfe is likely to take an active role against Polyheme's approval. Northfield shares closed Thursday down 22.2% to 77 cents.