included in this press release
that are not a description of historical facts are forward-looking
statements that involve risks and assumptions that, if they materialize or
do not prove to be accurate, could cause ADVENTRX's results to differ
materially from historical results or those expressed or implied by such
forward-looking statements. These risks and uncertainties include, but are
not limited to: the risk that preclinical results are not indicative of the
success of subsequent clinical trials and that products will not perform as
preclinical data suggests or as otherwise anticipated; the risk that
ADVENTRX will be unable to raise sufficient capital to fund the projects
necessary to meet its anticipated or stated goals and milestones, including
funding the continued development of ANX-514; the FDA's views on the
appropriateness of seeking marketing approval of ANX-514 under Section
505(b)(2); difficulties or delays in developing, testing, manufacturing and
marketing and obtaining regulatory approval for ANX-514, including
receiving necessary regulatory approvals for clinical trials of ANX-514, in
a timely manner or at all, and the potential for automatic injunctions
regarding FDA approval of ANX-514 and other challenges by patent holders
during the Section 505(b)(2) process; uncertainty under Section 505(b)(2)
resulting from legal action against the FDA and the potential that future
interpretations of Section 505(b)(2) could delay or prevent the FDA from
approving any Section 505(b)(2) NDA; the potential for regulatory
authorities to require additional preclinical work or other clinical
requirements to support regulatory filings; patent and non-patent
exclusivity covering docetaxel; and other risks and uncertainties more
fully described in ADVENTRX's press releases and periodic filings with the
Securities and Exchange Commission. ADVENTRX's public filings with the
Securities and Exchange Commission are available at
ht
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