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Strategies & Market Trends : January Effect 2007 -- Ignore unavailable to you. Want to Upgrade?

To: Carl Worth who wrote (19)	12/19/2006 7:18:26 PM
From: RockyBalboa	Respond to of 94

NFLD - not too closely followed. I do remember NFLD from the time of the Dreyfus affair in 1998 when the fund would buy up a massive amount of shares in several microcaps and smallcaps, ... I had more to do with its competition: shorting BioTime and I purchased shares of Cohesion (also having a blood subsitute) and Fusion. But this is also a long time back.

To: Carl Worth who wrote (19)	12/19/2006 8:30:17 PM
From: gcrispin	Read Replies (1) \| Respond to of 94

This is not good news and the after-hours trading confirms it. From the WSJ Northfield Laboratories Inc., seeking to be first to market with a blood substitute, said there were 46 patients who died after being giving its blood substitute in a study of trauma patients, compared with 35 who died given standard treatment. The findings appear to be a major setback for the Evanston, Ill., company and for the overall effort to get federal approval for a blood substitute. Northfield said there were "discrepancies" in the data from the trauma study and that it plans to further evaluate them. Thus, it said, it considers the findings announced Tuesday to be "preliminary." Moreover, Chief Executive Steven A. Gould said in a conference call that the death-rate findings weren't statistically significant. He said the company plans to "continue to move forward toward submission" of the data to the Food and Drug Administration. After hearing the company's conference call, William D. Hoffman, chief of cardiac-surgery critical care at Massachusetts General Hospital and former medical director of another blood-substitute company, said, "In my opinion, it would be irresponsible and unprecedented to grant an approval for PolyHeme based on these data." He said that "a 5% absolute difference in mortality in favor of the control arm of the study is too great" for the findings to be considered "non-inferior." The study was designed to evaluate whether the blood substitute, called PolyHeme, was either superior to, or not worse than, standard therapy. The announcement of preliminary data don't definitely answer that question, but the raw numbers would appear to be a big problem for Northfield. In the study, badly hemorrhaging trauma patients were randomly assigned to PolyHeme, or to standard therapy, which is saline solution in the ambulance and donor blood in the hospital. The company said there were a total of 722 patients in the study, and that 349 patients got the blood substitute and that 363 got standard treatment. However, it said it has found data errors in the preliminary findings and that it plans to provide full results as soon as possible. Dr. Gould said that in the 586 patients for whom there were no data errors, there were 30 deaths in the PolyHeme group and 28 in the standard-therapy group. Dr. Gould said that, in the 586 patients, PolyHeme did achieve "noninferiority" in the study. The results would appear to leave the FDA with a quandary: Can the agency approve a blood substitute that may still be worse than standard therapy? The way the study was set up, PolyHeme can be found "noninferior" to saline and donor blood, and still not be "the same as" saline and blood. Instead, it means that, statistically, the product hasn't been proven better or worse. That seemingly technical distinction makes a big difference, as seen in the trauma study's protocol, or methodological plan, which was made available to The Wall Street Journal. This document shows that PolyHeme could be deemed "noninferior" and -- because of the way the term is defined and the relatively small size of the study -- still be potentially as much as nearly 7% worse than blood and saline in terms of patients' deaths. "It's obvious that a nearly 7% absolute difference would not be acceptable for getting a license," said Dr. Hoffman. "There's no way the FDA will give them a license if it can be almost 7% worse than blood." FDA officials didn't respond to questions about licensing standards. In the vast majority of clinical trials, a company is required to show that its drug is better than something else, either a placebo or the standard therapy for an illness. In the Northfield study, its blood substitute can either be superior, inferior or -- the middle ground -- noninferior. Northfield shares fell 20% in heavy trading Tuesday afternoon, well before the conference call in which results were disclosed. The design of the Northfield trauma study has drawn criticism in part because of an earlier Northfield study. In that surgery trial, 10 of 81 patients on Northfield's PolyHeme had heart attacks, of whom two people died. None of the 71 patients getting donor blood had a heart attack in that earlier study. Northfield quietly shut down that trial and didn't publicly disclose the results, saying only in a 2001 federal filing that the study was taking too long to complete. The company has since, in interviews with The Wall Street Journal, said the heart attacks may have not been caused by the blood substitute. The current Northfield study in trauma patients finished enrolling the last of its U.S. patients this summer. The "primary endpoints" -- or main goals of the study -- involve measuring death rates at one and 30 days after an accident. A third primary goal measures permanently disabling "serious adverse events."