Updated from 12:21 a.m. EDTThe 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.
However, on a Jan. 12 conference call covering the company's fiscal second quarter, CEO Steven Gould said the company was preparing for a potential meeting of the FDA's blood product advisory committee. Soon after the FDA rejects Polyheme on or about April 30, Northfield will run out of cash. Earlier this week, the company raised $1.4 million, which gives it just enough money to remain in business for days, perhaps weeks, after April 30. The $1.4 million raised by Northfield diluted the company's current shareholders by almost 50%. Northfield is trying to win a race to get the first human blood substitute approved, a race that other companies like Biopure ( BPUR) and Baxter ( BAX) have failed previously. It's been more than two years since Northfield first announced the failure of the phase III Polyheme study, but recall that the death rate for trauma patients treated with Polyheme was over 13% compared with a death rate of just under 10% for patients treated with saline and blood. Scarier was the study's safety data, which went against Polyheme in every way measured. Patients treated with Polyheme reported more serious adverse events, more heart attacks and greater risks to the kidneys than the control patients. These negative data didn't stop Northfield from seeking FDA approval for Polyheme. But by not holding an advisory committee meeting next month to review the blood substitute, the FDA appears to have all the information required to make an approval decision already. And that decision will likely be the end of Polyheme and Northfield Labs.