- FDA update expected imminently
- Successfully completed initial project for Cosmetics company
- AMEX appeal continuing
TORONTO, Aug. 13 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced unaudited financial results for the second quarter fiscal 2008 ended June 30, 2008 ("Q2 2008").
"The second quarter of 2008 continued to be one of tremendous focus and dedication in resolving some of the challenges that we have faced," said Brent Norton, president and CEO of PreMD. "We believe that we have made significant progress with the US Food and Drug Administration (FDA) regarding our appeal of the non-substantially equivalent (NSE) letter for our 510(k) submission. We are encouraged by the FDA's request for additional analysis of the data and believe that this is a positive step towards regulatory approval in the U.S. The request follows several constructive discussions over the past three months. We maintain that our clinical data warrants the approval of our non-invasive skin cholesterol test and that we are on a path towards resolving the outstanding matters and achieving our objectives. We are also pleased to continue working with our partner, AstraZeneca Pharmaceuticals LP, and our medical colleagues throughout the appeal process." PreMD has complied with all the FDA's requests and it is anticipated that PreMD will be hearing from the FDA imminently and will continue to release any news as it becomes available.
Dr. Norton continued, "Despite the setbacks faced, management has also
focused on business development activities during this quarter. We are
driven and will continue to expand on our leading position in the skin
cholesterol testing field through our diverse pipeline of products and
capabilities. As previously announced in June, we also successfully
completed a project for one of the leading health and beauty organizations
in the world and expect to enter
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