PreMD Reports Further Positive Meetings with the FDA
2008年6月13日 - 10:00PM
PRニュース・ワイアー (英語)
Will work together over next 60 days to try to resolve remaining
issues TORONTO, June 13 /PRNewswire-FirstCall/ -- Predictive
medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced
that the Company has had further meetings with the U.S. Food and
Drug Administration (FDA) in an effort to resolve the outstanding
issues associated with obtaining broader regulatory clearance for
its non-invasive skin cholesterol test. Over the next 60 days PreMD
and the FDA will work together to try to obtain consensus on
certain conclusions from the existing clinical data in order to
develop appropriate labeling for the product. "The FDA has provided
constructive comments and assistance in defining the most
appropriate strategy for clearance, and we look forward to a
productive outcome at the end of the 60 days," said Brent Norton,
president and CEO of PreMD. About PreMD Inc. PreMD Inc. is a leader
in predictive medicine, dedicated to developing rapid, non-invasive
tests for the early detection of life-threatening diseases. PreMD's
cardiovascular products include a line of non-invasive skin
cholesterol tests. PreMD's other skin cholesterol products include
PREVU(x) LT, a skin cholesterol test designed for use in the life
insurance industry. The Company's cancer tests include
ColorectAlert(TM), LungAlert(TM) and a breast cancer test. PreMD's
head office is located in Toronto, Ontario and its research and
product development facility is at McMaster University in Hamilton,
Ontario. For more information about PreMD, please visit
http://www.premdinc.com/. This press release contains
forward-looking statements. These statements involve known and
unknown risks and uncertainties, which could cause the Company's
actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the successful development or marketing of the
Company's products, the competitiveness of the Company's products
if successfully commercialized, the lack of operating profit and
availability of funds and resources to pursue R&D projects, the
successful and timely completion of clinical studies, product
liability, reliance on third-party manufacturers, the ability of
the Company to take advantage of business opportunities,
uncertainties related to the regulatory process, and general
changes in economic conditions. In addition, while the Company
routinely obtains patents for its products and technology, the
protection offered by the Company's patents and patent applications
may be challenged, invalidated or circumvented by our competitors
and there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. Investors
should consult the Company's quarterly and annual filings with the
Canadian and U.S. securities commissions for additional information
on risks and uncertainties relating to the forward-looking
statements. Investors are cautioned not to rely on these
forward-looking statements. PreMD is providing this information as
of the date of this press release and does not undertake any
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
otherwise. DATASOURCE: PreMD Inc. CONTACT: Ron Hosking,
Vice-President, Finance, Tel: (416) 222-3449, Email: ; Michelle
Rabba, Manager, Corporate Communications, Tel: (416) 222-3449 ext.
25, Email:
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