Northfield, Polyheme Not Long for This World
Updated from 12:21 a.m. EDT
The final nail in Northfield Labs' (NFLD) coffin is set, just waiting for regulators to bring down the hammer.
On Tuesday, the Food and Drug Administration released the agenda for an April 1-2 meeting of the agency's blood products advisory committee and conspicuously absent is any review of Northfield's experimental human blood substitute, Polyheme.
The FDA's decision to not convene a panel of blood experts to review the possible approval of Northfield's Polyheme is a nearly definitive signal that the agency has already made an internal decision to reject the blood substitute on or before its action date of April 30.Polyheme aims to be the first-ever human blood substitute approved by the FDA. As such, it's nearly impossible to conceive a scenario by which the FDA would approve a groundbreaking product like that without the input and recommendations of outside experts. The odds of a Polyheme approval already were set at slim to none because the blood substitute failed its only phase III study and has an ignominious safety record. Northfield's stock price has plunged from about $17 December 2006 (before the negative results of the Polyheme phase III study were announced) to Tuesday's closing price of 46 cents. Shares were recently down 9.7% to 42 cents. Northfield spokeswoman Sophia Twaddell said the company isn't aware of any plans for an FDA advisory committee to review Polyheme. "Since the submission of our Biologic License Application (BLA) in October 2008, we have received multiple requests from FDA for data clarification and supplementation; in response, we have provided several amendments to our original BLA. The process of FDA site inspection and audit has begun at a number of the 32 institutions that participated in our Phase III trial. FDA has also conducted a pre-license inspection of our manufacturing facility," said Twaddell, in an email response to questions.
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