This item is part of Stockwatch's value added news feed and is only available to Stockwatch subscribers.Here is a sample of this item:Angiotech Pharmaceuticals provides update on Bio-Seal(TM) 510(K) submission 2009-10-19 16:30 ET - News Release VANCOUVER, Oct. 19 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that it has received correspondence from the FDA regarding its 510(k) submission for Bio-Seal, stating that Bio-Seal is a class III device that requires Pre-Market Approval (PMA) for FDA marketing clearance. As a result, Angiotech is reviewing its options with respect to this product candidate, including possibly appealing this FDA decision, and is discussing the possible preparation of a PMA submission with its partner, Biopsy Sciences, LLC. Should Angiotech elect to continue to pursue development or regulatory approvals for this product candidate that require the company to incur material expense, Angiotech will provide further updates in its public disclosure. Angiotech has not incurred material expense to date with respect to activities regarding this product candidate. "While we continue to believe in the potential of Bio-Seal, we are assessing our next steps with respect to this product candidate in the United States, given the substantial number of competing opportunities we are funding and pursuing at this time," said Dr. William Hunter, President and CEO of Angiotech. "We expect that our Quill SRS, Option IVC Filter and 5-FU anti-infective technologies will command significant attention during 2010, and at this stage offer the most substantive potential among our many novel technology opportunities." The remainder is available to Stockwatch subscribers.
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