Somehow this does not sound all that positive. After all this time why should more information be requested?
Friday January 9, 3:41 pm Eastern Time
Company Press Release
SOURCE: North American Vaccine, Inc.
North American Vaccine Advised by FDA that CERTIVA(TM) is on Track for
Completing Final Steps for Licensure
BELTSVILLE, Md., Jan. 9 /PRNewswire/ -- North American Vaccine (Amex:
NVX - news) announced today that it has been advised by the U.S. Food
and Drug Administration (FDA) that CERTIVA(TM) is on track for
completing the final steps for licensure. CERTIVA(TM) is the Company's
investigational vaccine against diphtheria, tetanus, and pertussis
disease. This information was conveyed to the Company at a meeting held
with FDA officials this week. At that meeting the FDA expressed its
objective of promptly completing the review process for CERTIVA(TM).
Towards this end, the FDA has requested additional information which the
Company intends to submit shortly. Based on its meeting with the FDA,
the Company anticipates that the regulatory review process could be
completed during the first quarter of 1998 or shortly thereafter. This
is a forward-looking statement and the factors which may affect its
outcome include the ability of the Company to timely provide the
information it intends to submit, the acceptability of the information
being submitted, the time it takes for the FDA to complete its review pr
ocess and the acceptability of the Company's applications in their
entirety, among other factors. There can be no assurances given as to
the final FDA determinations or that CERTIVA(TM) will receive regulatory
approval in the anticipated timeline. The regulatory review of a vaccine
product is an ongoing, interactive process. Accordingly, the Company
does not intend to continuously issue periodic updates until CERTIVA(TM)
completes its regulatory review.
North American Vaccine, Inc. is engaged in the research, development and
production of vaccines for the prevention of human infectious diseases.
North American Vaccine news releases are available on the Company's web
site at nava.com.
This press release contains certain forward-looking statements, which
are made pursuant to the safe harbor provisions of the Securities
Litigation Reform Act of 1995. Investors are cautioned that
forward-looking statements involve risks and uncertainties which may
affect the Company's business and prospects, including without
limitation the requirement for regulatory approval of products by the
FDA, nature of competition, effective marketing, and uncertainties
relating to clinical trials all as discussed in the Company's filings
with the U.S. Securities and Exchange Commission, including its annual
reports on Form 10-K, quarterly reports on Form 10-Q and current reports
on Form 8-K.
SOURCE: North American Vaccine, Inc. |
