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COPYRIGHT 2001 PR Newswire Association LLC
- Company Provides Update on Regulatory Program in the U.S.-
TORONTO, May 31 /PRNewswire/
- (NASDAQ: HMSL, TSE: HML) Today at Hemosol's Annual and Special Meeting of Shareholders, Company President and Chief Executive Officer Mr. John W. Kennedy will highlight the Company's accomplishments over the past year and outline management's goals for 2001 and beyond.
"The most critical event of last year was undeniably the successful conclusion of our pivotal Phase III Canada/U.K. Hemolink(TM) trial. Final analysis of the randomized, doubled-blinded, controlled Phase III trial showed conclusively that Hemolink(TM) safely reduces transfusion of donor red blood cells in patients undergoing routine coronary artery bypass grafting or CABG surgery. These positive results allowed us to file for marketing approval in Canada and Europe," said Mr. Kennedy.
During the meeting, Mr. Kennedy will highlight many of the past year's important events, including:
- Successful completion of its Phase III Canada/U.K Hemolink(TM) trial;
- Filing for marketing approval in Canada and, based on the strength of
the submission, receiving priority review;
- Commencement of a pivotal Phase III trial of Hemolink(TM) in the U.S.;
- Increased Hemolink(TM) production at the Company's existing facility by
more than three-fold to a capacity of 25,000 units per year;
- Ground breaking at its new 300,000 unit, state-of-the-art Hemolink(TM)
manufacturing facility;
- Securing of $47.5 million in credit facilities to finance the new
facility;
- Signing of a letter of intent regarding proposed marketing alliance
with Dompe Farmaceutici S.p.A. for southern Europe; and
- Raising of more than $80 million in four separate equity transactions.
Subsequent to the end of the Company's fiscal year, Hemosol marked the following events:
- Filing for marketing...
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