Northfield labs (NASDAQ:NFLD)
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Northfield Laboratories (NASDAQ: NFLD) released the
following statement today in response to news reports that Senator
Grassley of Iowa has raised questions about the Northfield trauma
trial research protocol:
Northfield is confident that the study is being conducted with the
utmost concern for patient safety and in accordance with all
applicable regulations.
Northfield has communicated with FDA, and the status of Company's
Pivotal Phase III trial remains unchanged and will continue.
On four occasions, after 60, 120, 250, and 500 patients had been
enrolled and followed for 30 days, the Independent Data Monitoring
Committee (IDMC) responsible for overseeing this study thoroughly
reviewed all safety data. On all four occasions, the IDMC recommended
that the study continue without modification. On February 23, 2006,
the IDMC reiterated its findings and its recommendation that the trial
continue to completion:
"As has been reported to Northfield Laboratories regarding the
final assessment of the interim data, including 500 randomized
patients, there were no statistically significant trends or safety
issues identified to warrant modification or other changes in the
current protocol and patient recruitment. The IDMC conclusion is that
completion of the trial is appropriate with completion of datasets and
final analysis indicated."
Northfield intends to cooperate fully with any review of Finance
Committee. The Company continues to believe that PolyHeme has the
potential to fundamentally improve the early treatment of injured
patients, whether trauma victims at home or combat casualties on the
battlefield.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying resuscitative fluid, PolyHeme(R), for the treatment of
urgent, large volume blood loss in trauma and resultant surgical
settings. PolyHeme(R) is a solution of chemically modified human
hemoglobin that requires no cross matching and is therefore compatible
with all blood types. It has a shelf life in excess of 12 months.
Enrollment is currently underway in a pivotal Phase III trial of
PolyHeme(R) beginning in the pre-hospital setting. For further
information, visit www.northfieldlabs.com.
This press release may contain forward-looking statements
concerning, among other things, Northfield's future business plans and
strategies and clinical and regulatory developments affecting our
PolyHeme(R) red blood cell substitute product. These forward-looking
statements are identified by the use of such terms as "intends,"
"expects," "plans," "estimates," "anticipates," "should," "believes"
and similar terms. These forward-looking statements involve inherent
risks and uncertainties. Our actual results may therefore differ
materially from those predicted by the forward-looking statements
because of various factors and possible events, including our ability
to obtain FDA approval to market PolyHeme commercially, the
availability of capital to finance our clinical trials and ongoing
business operations, our ability to obtain adequate supplies of raw
materials and to manufacture PolyHeme in commercial quantities, our
ability to market PolyHeme successfully, the possibility that
competitors will develop products that will render PolyHeme obsolete
or non-competitive, our ability to protect our intellectual property
rights, the possibility that we may be subject to product liability
claims and other legal actions, our dependency on a limited number of
key personnel, the uncertainty of third party reimbursement for our
product and other risks and uncertainties described from time to time
in our periodic reports filed with the Securities and Exchange
Commission, including our most recently filed quarterly report on Form
10-Q and annual report on Form 10-K. These forward-looking statements
speak only as of the date of this press release. We do not undertake
any obligation to update or publicly release any revisions to
forward-looking statements to reflect events, circumstances or changes
in expectations after the time such statement is made. All subsequent
written and oral forward-looking statements attributable to Northfield
or any person acting on our behalf are qualified by this cautionary
statement.