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SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Rule 14a-6(e)(2))
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NORTHFIELD LABORATORIES INC.
(Name of Registrant as Specified in its Charter)
C. ROBERT COATES
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(Name of Person(s) Filing Proxy Statement if other than the Registrant)
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0-11(a)(2) and identify the filing for which the offsetting fee was paid
previously. Identify the previous filing by registration statement number,
or the Form or Schedule and the date of its filing.
1) Amount Previously Paid:
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3) Filing Party: C. Robert Coates
4) Date Filed: September 12, 2002
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NORTHFIELD LABORATORIES' TRACK RECORD WITH THE FDA
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NORTHFIELD
STOCK
DATE EVENT PRICE
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April 2, Northfield Laboratories, Inc. (Northfield) announces $12.00
1997 through a press release of its own that it "has
received clearance from the Food and Drug
Administration to begin Phase III trials of its blood
substitute, PolyHemeT."
The press release also states that "The randomized,
controlled study will include about 250 elective
surgery patients and once underway is expected to take
12 months to complete."
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August 12, Northfield announces through a press release of its $13.94
1998 own that the FDA had asked it "to expand the number of
patients in Phase III clinical trials of its blood
substitute, PolyHeme."
The press release further states that "[a]t present,
Northfield and the FDA have agreed that at least 600
patients would need to participate in an expanded
study, seeking to balance the public's concern about
blood substitute safety with the compelling need to
bring such a product to market."
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August 16, Northfield announces through a press release of its $19.84
2001 own that "it has completed preparation of all of the
components of its Biologics License Application (BLA),
including collection and analysis of its clinical
trial data for PolyHeme."
The press release also states that Richard DeWoskin,
chairman and chief executive officer said, "[w]e are
pleased with the results from our clinical studies and
believe the safety and efficacy data that we will
present to the FDA are compelling."
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August 28, Northfield reports that it "has submitted a Biologics $17.30
2001 License Application (BLA) to the Food and Drug
Administration (FDA) seeking approval to market its
patented blood substitute product, PolyHeme, as an
ideal oxygen-carrying resuscitative fluid for use in
the treatment of urgent, life-threatening blood loss."
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September 4, Northfield announces that "the company has requested $16.25
2001 priority review and fast-track designation, which it
hopes will lead to accelerated approval as described
in the FDA regulations."
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October 11, Northfield announces through a press release of its $13.01
2001 own that "today" it had "presented data from trauma
trials of its patented blood substitute, PolyHeme, at
the American College of Surgeons annual meeting in New
Orleans."
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October 12, The website www.docguide.com reports that "Dr. Steven $12.87
2001 A. Gould, president of Northfield Laboratories" had
presented "the study at the 87th Clinical Congress of
the American College of Surgeons."
The article, "Polymerized Hemoglobin Safe for Rapid,
Massive Transfusion in Trauma Patients" also states
that "[i]n the study, 171 trauma patients were offered
PolyHeme in place of red blood cells."
Furthermore, "Dr. Gould said the study represented a
'simulated' design since 'the patients were treated in
a hospital where blood was available.'"
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October 15, Northfield announces in its Quarterly Report (SEC form $12.71
2001 10-Q) that "[b]onus payments in recognition of the
Company filing a Biologics License Application ("BLA")
with the FDA for PolyHeme increased payroll expense by
$560,000 in the first quarter of fiscal 2002 as
compared to the first quarter of fiscal 2001."
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November 19, Northfield reports that it "received comments from The $13.25
2001 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."
Northfield's press release also included the following
comment from Richard DeWoskin, "[r]efusals for first-
time submissions are not uncommon."
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June 27, The Chicago Tribune reports in a section titled "Bid $ 4.22
2002 for Northfield Lab's board" that, Northfield Chief
Executive Richard DeWoskin had said, "the application
process is not the issue." DeWoskin also added that
"the FDA's problems with the application are focused
on certain manufacturing processes and 'chemistries'
the company plans to use in the production of
Poly[H]eme."
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July 26, An article by TheStreet.com titled "Northfield CEO: $ 5.45
2002 PolyHeme May Need More Trials" by Adam Feuerstein
reports that Dr. Gould had said "Yes, our trial was
uncontrolled"
The article further states that, "Northfield's
clinical trial enrolled just 171 patients, far fewer
than the 600 to 700 patients enrolled by the company's
blood substitute rivals.
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KEY QUESTIONS:
* Why did Northfield submit a BLA based on 171 patients when it had agreed
with the FDA in 1998 that "at least 600 patients" would be needed?
* Why did Northfield submit a BLA based on a trial that "was uncontrolled"
when it had announced back in 1997 that the study would be a "controlled"
one?
* Why did Northfield say it would take "12 months to complete" the study, but
almost 4 years later (2001) they still had not enrolled 250 patients (the
initial goal of the study)?
* Why did Northfield not announce to its shareholders any changes in its
trial strategy?
* Why did Northfield's Dr. Steven Gould and other senior managers pay them-
selves over half a million dollars in bonuses for an application that was
not accepted (filed) by the FDA?
* Why did Northfield call the Refusal-To-File "not uncommon" when data from
CBER shows that over the last three years it has only happened 3 out of 165
applications or 1.8% of the time?
* What exactly are the manufacturing process issues the FDA has "problems
with?"
* Who was in charge of clinical trial design at Northfield?
* What role did Northfield's paid consultant, Dr. Paul Ness, play in
Northfield's filing with the FDA?
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