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8-K - FORM 8-K - NAVIDEA BIOPHARMACEUTICALS, INC. | v325529_8-k.htm |
EX-99.1 - EXHIBIT 99.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v325529_ex99-1.htm |
Exhibit 99.2
Navidea Provides Lymphoseek® NDA Update Statement
October 10, 2012
On September 24, 2012, Navidea issued a statement that, as part of its continuing effort to secure regulatory NDA approval
for Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a Type A meeting with the FDA had been scheduled to advance
the Company's planned response to the Agency regarding deficiencies in current Good Manufacturing Practice (cGMP) identified during
inspections at third-party manufacturing facilities.
The Company has now successfully completed the Type A meeting
with the FDA and has received clarifying guidance from the Agency in regard to the cGMP issues noted in the FDA's Complete Response
Letter (CRL) received on September 10, 2012 and the requirements for the Company’s response to the CRL for the Lymphoseek
NDA.
The meeting confirmed that the scope of the Navidea resubmission will be focused on the previously noted cGMP manufacturing deficiencies
observed at third-party manufacturing facilities. The meeting further affirmed the requirements that the Company must address in
its resubmission.
The Company continues to believe this process will not entail a re-review of the full NDA. The Company also believes that a majority of the requirements needed from the third-party manufacturing facilities to address the noted deficiencies have already been completed.
Navidea anticipates providing further information regarding
the timing for resubmission and related matters by early November. Gaining approval for Lymphoseek continues to be the priority
of the Company as we continue to develop our pipeline and advance Navidea's position as a leading precision diagnostics company.
Safe Harbor Statement
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made
by or on behalf of the Company. Statements on this web page, which relate to other than strictly historical facts, such as statements
about the Company's plans and strategies, expectations for future financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the Company's products are forward-looking statements within the
meaning of the Act. The words "believe," "expect," "anticipate," "estimate," "project,"
and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that
such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated
results due to many factors including, but not limited to, the Company's continuing operating losses, uncertainty of market acceptance
of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding,
dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks
of development of new products, regulatory risks and other risks detailed in the Company's most recent Annual Report on Form 10-K
and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking
statements.