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PreMD Announces FDA Decision On POC Skin Cholesterol Test
Predictive medicine company
PreMD Inc. (TSX: PMD; Amex: PME) announced that it has received a
non-substantially equivalent (NSE) letter from the U.S. Food and Drug
Administration (FDA) regarding the 510(k) submission for an expanded
regulatory claim on its point-of-care (POC) skin cholesterol test. The
company expects to evaluate its options as part of the plans to address
this issue.
"We are very disappointed with this decision by the FDA regarding our
510(k) submission. We believe we have provided adequate information to
support clearance and continue to believe that our product merits clearance
by the FDA," said Brent Norton, president and chief executive officer of
PreMD. "The company is pursuing the next steps in addressing the decision
and we will work through the process as expeditiously as possible. We
continue to believe that this test fulfills a need for screening
asymptomatic patients for risk of cardiovascular disease. Furthermore, our
recent clinical achievements such as our presentation at the American Heart
Association and scheduled publication in the American Journal of Cardiology
for April show that we are supported in our belief of the strength of our
product. The company has adequate cash to support operations through the
near term. However, we will continue to evaluate and decrease spending
throughout the organization to ensure our ability to execute the necessary
tasks."
The FDA's primary grounds for rejecting the claim relate to the
clinical utility of evaluating skin cholesterol with carotid wall intima
thickness (CIMT) as the clinical endpoint. PreMD submitted the 510(k)
application to the FDA in June 2007 based on a study design that was
previously accepted as appropriate by the FDA. Subsequently, the FDA
requested additional information regarding statistical clarification on the
data submitted. The company promptly provided the information requested and
believes that it addressed those concerns to the best capabilities of the
company. PreMD was not aware of the FDA's issue or concerns from previous
discussions.
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, planned to be marketed and distributed by
AstraZeneca Pharmaceuticals. 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 success of a plan for regaining compliance with certain
continued listing standards of the American Stock Exchange, 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.
PreMD Inc.
http://www.premdinc.com
PreMD Announces FDA decizie privind POC Skin Test Colesterol - PreMD Announces FDA Decision On POC Skin Cholesterol Test - articole medicale engleza - startsanatate