Navigation Links
PreMD Reports Further Positive Meetings with the FDA
Date:6/13/2008

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.


'/>"/>
SOURCE PreMD Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. PreMD Appeals American Stock Exchange Delisting Notification
2. PreMD Reports First Quarter Results
3. PreMD Provides Update on FDA Review
4. PreMD Reports Fiscal 2007 Results
5. PreMD Inc. Completes Debenture Financing
6. PreMD Inc. Signs Agreement with Cosmetics Conglomerate
7. PreMD Inc. Announces Debenture Financing
8. PreMD Initiates FDA Review Process and Provides Corporate Update
9. PreMD Announces FDA Decision on POC Skin Cholesterol Test
10. PreMD Announces Valuable Data on PREVU(x) LT Life Insurance Product
11. PreMD Inc. Provides Corporate Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... ... Center for Autism and Related Disorders (CARD) Portland today announced plans to host ... other developmental disabilities. The group, which is being launched with the help of Robbie ... share stories and advice, seek help, and continue their education on how to best ...
(Date:12/2/2016)... ... December 02, 2016 , ... Dr. Raffi Hovsepian, a leading ... the 2016 “Guide to America’s Top Plastic Surgeons” for seven consecutive years. The ... education, experience, and professional associations. , One the most frequently honored surgeons ...
(Date:12/2/2016)... Cleveland, OH (PRWEB) , ... December 02, 2016 ... ... provider of veterinarian diagnostic imaging systems and the first company to ... Robot With a Heart at their tradeshow booth # 941 for the American ...
(Date:12/2/2016)... ... 02, 2016 , ... Clarify Health Solutions, Inc., the leading ... in an initial round of funding. The round was led by experienced investors ... receive far better care through the application of the best technologies from other ...
(Date:11/30/2016)... (PRWEB) , ... November 30, 2016 , ... ... to announce that we have been designated as a Cigna Infertility Center of ... exceed rigorous performance standards. , “It’s an honor to be designated a ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... - bioLytical lanza el INSTI HIV Self Test para el mercado ... Continue Reading ... New: INSTI Self Test! ... , bioLytical Laboratories (la "Compañía"), un líder mundial ... lanzamiento de su INSTI HIV Self Test  a África con una versión de ...
(Date:12/2/2016)... According to the latest market report published by ... Reprocessors: Single Basin Automated Endoscope Reprocessors Product Type Segment Anticipated ... the global automated endoscope reprocessors market was valued at US$ 740.6 Mn ... of 7.2% during an eight-year forecast period 2016-2024, to reach ... ...
(Date:12/2/2016)... , Dec. 2, 2016 In the ... sources apart from those derived from C. sativa, the ... Universita` di Napoli Federico II , the Universita` ... the first comprehensive, critical, integrated and unified inventory of ... article focuses on the remarkable chemical and structural ...
Breaking Medicine Technology: