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SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934
Filed by the Registrant [ ]
Filed by a Party other than the Registrant [X]
Check the appropriate box:
[ ] Preliminary Proxy Statement
[ ] Confidential, for Use of the Commission only (as permitted by
Rule 14a-6(e)(2))
[ ] Definitive Proxy Statement
[ ] Definitive Additional Materials
[X] Soliciting Material Under Rule 14a-12
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)
Payment of Filing Fee (Check the appropriate box):
[X] No fee required.
[ ] $125 per Exchange Act Rules 0-11(c)(1)(ii), 14a-6(i)(1), 14a-6(i)(2) or
Item 22(a)(2) of Schedule 14A.
[ ] Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11.
1) Title of each class of securities to which transaction applies:
2) Aggregate number of securities to which transaction applies:
3) Per unit price or other underlying value of transaction computed
pursuant to Exchange Act Rule 0-11 (Set forth the amount on which
the filing fee is calculated and state how it was determined):
4) Proposed maximum aggregate value of transaction:
5) Total fee
paid:
[ ] Fee paid previously with preliminary materials.
[ ] Check box if any part of the fee is offset as provided by Exchange Act Rule
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:
2) Form, Schedule or Registration Statement No.:
3) Filing Party: C. Robert Coates
4) Date Filed: September 03, 2002
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Press Release
SOURCE: C. Robert Coates
ROBERT COATES AND BERT WILLIAMS JOINED BY EXPERT ON FDA
LAKE FOREST, Ill., Sept. 4 -- C. Robert Coates, running with Bert Williams as
independent candidates for seats on the board of Northfield Laboratories Inc.
(Nasdaq: NFLD), said Dr. Jur Strobos, former Director of Policy Research for the
U.S. Food and Drug Administration, has joined the Coates/Williams team as an
adviser.
"The future success of Northfield depends on its interaction with the FDA," said
Coates. "For that reason, we have added Jur Strobos, a recognized expert, to our
advisory group."
Dr. Strobos received his M.D. at the University of Chicago, practiced as a
trauma surgeon, and then received his J.D. at the University of Pennsylvania. He
served as Director of Policy in the FDA's Office of the Commissioner for 3-1/2
years before re-entering the private sector in 1995 as a shareholder/partner of
the law firm of Greenberg Traurig. He is now with Olsson, Frank & Weeda in
Washington, D.C.
Since 1986, Dr. Strobos has specialized in new medical product development. His
area of expertise includes development of successful strategies for, and
management of, the clinical and regulatory process for new medical products.
This work includes the design, completion and submission of clinical,
statistical, chemical, compliance and other scientific data supporting new drug
or device approval as well as associated activities such as public relations,
development of marketing strategies and communications with professionals,
support for public offerings and negotiations with potential strategic alliance
partners.
Dr. Strobos' experience will be valuable to shareholders in understanding
Northfield's dealings with the FDA. Northfield has made repeated references to
its ongoing constructive dialogue with the agency. However, it has been almost a
year since the FDA issued Northfield a refusal-to-file (RTF) letter for its only
potential revenue source, PolyHeme. And the company has never provided a
detailed account to its shareholders.
Dr. Strobos, who was at the FDA when the original RTF regulation was issued, and
is considered a foremost authority on the subject, addressed Northfield's RTF,
saying: "I have concerns about Northfield's expertise in dealing with the FDA.
Regulatory expertise is essential for this company. For example, an RTF letter
is provided by the FDA only in the setting of a wholly inadequate filing that is
apparent to anyone on even a cursory examination. The purpose of an RTF is not
to provide an opinion on the safety and efficacy of the product but to tell the
company that simple well known and required components of an application are
missing."
The Center for Biologics Evaluation & Research (CBER) division of the FDA has
summarized data on filings and RTFs in its annual reports. Of 165 biologics
reviewed during the fiscal period 1999 to 2001 only three, or 1.8%, received an
RTF. (www.fda.gov/cber/inside/annrptpart5.htm). This is in direct contradiction
to a statement issued by Northfield Laboratories on Nov. 19, 2001 saying,
"Refusals for first-time submissions are not uncommon."
Dr. Strobos also addressed comments made by Northfield in an Aug. 29 press
release titled "Northfield Builds Support for PolyHeme in Medical and Scientific
Communities." Northfield said that as a result of the statements by Mr. Coates,
"it was necessary for Northfield to provide a letter to the FDA confirming that
Mr. Coates is not authorized to speak on behalf of Northfield and that we do not
share the views expressed in his press releases."
Dr. Strobos said, "A company should not send a letter to the FDA regarding a
proxy contest. No such response is required by the FDA. And, the candidate may
lose in which case his statements are irrelevant; or the candidate may win, in
which case the response will have to be withdrawn. It is simply not a wise
action."
Coates and Williams said the quickest way to realize shareholder value is to
bring in a major pharmaceutical company now to provide the necessary capital and
management talent to gain FDA approval for PolyHeme.
They remind shareholders to elect two directors who will represent their
interests and hold management accountable by casting the white ballots for the
September 13 election.
If you are a shareholder with comments, suggestions or questions about receiving
a Coates-Williams proxy, please call Simon Goldberg of the Robert Coates Group
at 1-800-295-0841, extension 240 or e-mail us at sgoldberg@rcoates.com .
SOURCE: C. Robert Coates