ORLANDO, Fla., March 26, 2009 (GLOBE NEWSWIRE) -- RedChip Visibility, a division of RedChip Companies Inc., has initiated coverage on Northfield Laboratories Inc. (Nasdaq:NFLD), developer of PolyHeme, a blood substitute awaiting approval by the Food & Drug Administration.
David Webber, RedChip Research Analyst, reported:
"We consider this stock a lottery ticket, with potential upside of at least 400% versus potential downside of 100%, depending on an approaching, make-or-break decision by the Food & Drug Administration. The FDA is reviewing PolyHeme for the resuscitation of trauma patients when red blood cells are unavailable, with a target action date of April 30th. The Street expects the agency to reject the application because the Phase III clinical trial missed its endpoint, the product is associated with serious adverse events, and the history of blood substitute development in general has been one of repeated failure."
"Nonetheless, although the mixed data imply long odds, we do not consider approval absolutely impossible given the FDA's risk/benefit yardstick for approvability," Webber continued. "There is a clear need for a product like this. The Phase III study missed by only a narrow margin and succeeded in a pre-specified secondary analysis, and the FDA understands that, for logistical reasons, the Phase III trial had to be conducted in a setting that may have understated PolyHeme's efficacy. We think that those factors imply that the door remains open a crack for an approval with restrictions."
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To learn more about Northfield Laboratories, visit http://www.redchip.com/visibility/investor.asp?symbol=NFLD
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