Northfield Labs has run into some difficulty with their application
for FDA approval of PolyHeme - a hemoglobin solution made
from human red blood cells. It looks to me like JWs will have to
settle for HemoPure at least at first. JWs in South Africa should
have access to HemoPure at this time but that is the only country
where it has been approved for use. HemoPure is the hemoglobin
solution made from bovine red blood cells.

Personally, I would prefer to use a blood product that comes from
humans, like red cells, over an animal blood product and I think
that most probably feel the same way.

The difference between a hemoglobin solution and red cells is
just the red cell membrane. So while the WTS continues to ban
red cells that could save many JW lives, they persist in their
fanciful delusion that something like hemoglobin, which makes
up 97% of the weight of a red cell, really isn't blood.

My suggestion to to anyone who has a medical need for packed
red cells is to take them unless the WTS can show you where in the
Bible Jehovah forbids the red cell membrane.

Lee

AT NORTHFIELD LABORATORIES: AT FRB|WEBER SHANDWICK:
Richard DeWoskin Leslie Hunziker Bill Schmidle Cindy Martin
Chief Executive Officer General Info. Analysts Media
(847) 864-3500 (312) 640-6760 (312) 640-6753 (312) 640-6741

FOR IMMEDIATE RELEASE
MONDAY, NOVEMBER 19, 2001

NORTHFIELD LABS RECEIVES FDA COMMENTS
ON APPLICATION FOR BLOOD SUBSTITUTE

Evanston, Illinois, November 19, 2001 -- Northfield Laboratories Inc. (Nasdaq/NMS: NFLD), a leading developer of an oxygen-carrying blood substitute for trauma situations, today reported that it received comments from The U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) on its Biologics License Application (BLA), submitted August 2001. CBER indicated that they are seeking additional information before accepting the application for filing and issued a Refusal-to-File letter to the company.

"Refusals for first-time submissions are not uncommon," said Richard DeWoskin, chief executive officer. "We are encouraged by the constructive information provided in CBER's initial response, and believe that while the next few months will be busy, there is good reason to expect that modifications resulting from this feedback will help us to progress to the next stage of the application process."

The company said the letter included both questions and comments about Northfield's blood substitute, PolyHeme, from CBER. Management said it will quickly begin the process of addressing these issues.

"The regulatory review will be a multi-stage process. There now will be a period of several weeks during which we will interact with CBER to clarify and come to fully understand the issues in question. This will lead to actions taken by the company to satisfy some of the agency's inquiries, but we believe these are manageable. Additionally, through interaction with CBER, we also believe we will address the agency's remaining issues on certain scientific and regulatory issues outlined in the letter over the next few months," said DeWoskin.

About the Company
Northfield Laboratories, founded in 1985, is a leading developer of an oxygen-carrying blood substitute. Its product, PolyHeme, is the only blood substitute undergoing clinical trials that has been tested at large enough dosages to be considered a substitute for acute blood loss in trauma and surgical settings. As a result of the process used to manufacture the blood substitute, essentially a solution of polymerized hemoglobin, PolyHeme has a longer shelf life than blood, requires no cross matching and does not transmit disease.

Statements in this release that are not strictly historical are "forward-looking" statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, which may cause the company's actual results in the future to differ materially from expected results. Northfield cautions that the FDA approval process for PolyHeme continues to be subject to significant risks and uncertainties. The FDA could refuse to accept Northfield's BLA in its current form. If Northfield's BLA is accepted, the FDA could deny its approval for the commercial sale of PolyHeme or could require additional clinical tests as a condition to its approval. If FDA approval for the commercial sale of PolyHeme is granted, the indication uses for which PolyHeme may be marketed could be significantly limited by the FDA. Other risks may include: competition from other blood substitute products; the company's and/or its representative's ability to successfully market and sell PolyHeme; the company's ability to manufacture PolyHeme in sufficient quantities; the company's ability to obtain an adequate supply of raw materials; the company's ability to maintain intellectual property protection for its proprietary product and to defend its existing intellectual property rights from challenges by third parties; the availability of capital to finance planned growth; and the extent to which the hospitals and physicians using PolyHeme are able to obtain third-party reimbursement, as described in the company's filings with the Securities and Exchange Commission.

Visit the Northfield website at: www.northfieldlabs.com

So now they get to use parts of COW blood.Serves them right,they deserve to MOO!...OUTLAW

Posted this to xjwnews.com.

XJW User Submitted News & Views at http://xjwnews.com

Wow, what a statement! Never is a long, long time. We’ll have to remember this one.

As for whether hemopure will EVER be approved, that is already decided. According to an article dated April 10, 2001 by Ravi Nessman, an Associated Press writer, Hemopure was approved for use in South Africa. (Ref: http://www.chl.ca/Health0104/10_blood-ap.html)

I appreciate your talents, and passions, Hawkaw, but let’s keep some balance here. Whether it’s Hemopure or some other brand, eventually a hemoglobin agent will gain universal approval. If Hemopure is not the one then it will undoubtedly have contributed significantly to the research making hemoglobin agents possible. To deny this would be denying science that has accomplished a great deal over the past few years, including its approval in the South Africa.

Like most other medical products has, I believe Hemopure will undergo improvements until it is finally successful in the broader market. If not as Hemopure than under some other name. Biopure, or some other agent with access to Biopure’s research, will see to it.

I had an interesting (for me, anyway) visit to the Red Cross this past week. I wanted to donate and the specific gravity test showed that I migntn't have enough iron in my blood. I asked questions about the test and the expression "iron" and found that the "iron" they were looking for was actually "hemoglobin" to which oxygen could attach itself.

As I said, a drop of my blood had flunked the "yes/no" test, so the next step was to actually get a sort of red blood cell count by percentage. So they took this little straw full of my blood, stopped it up with clay, placed it in a centrifuge machine and after several minutes pronounced me good to give! The technician showed me the straw which had separated the blood into plasma and hemoglobin.

Now, I've seen pie charts about how the blood is broken down, but this was my own blood separated before my very eyes into fractions. I had 42% red blood cells(=hemoglobin for all intents and purposes) which was plenty, and thus could continue the donation process.

There is no way that I could EVER, any more, convince MYSELF that ANY blood fraction is not fully BLOOD. And if ONE blood fraction is permissible despite the supposed Biblical prohibition against using it [even to save this precious gift of life from God], then ALL blood fractions are permissible.

Ain't no way around THAT!!!

Proof was in the straw!

outnfree

In dealing with fear, the way out is in -- Sheldon Kopp

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