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Biotech / Medical : Biopure Corp (BPUR)

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To: PartyTime who started this subject	8/14/2001 7:18:25 PM
From: sim1	Read Replies (1) of 544

Hemosol Announces Update on Regulatory Program in the U.S. TORONTO, Aug. 13 /PRNewswire/ - Hemosol Inc. (NASDAQ: HMSL, TSE: HML) today announced it has received verbal notification from the U.S. Food and Drug Administration (FDA), that in addition to the amendments previously discussed and agreed to with the FDA, the Company has now been asked to make further changes to its trial protocol to ensure acceptability of the efficacy analysis for inclusion in a Biologic License Application. Due to this new development the Company no longer believes a completion date in the first quarter of 2002 is achievable for the pivotal study. Until Hemosol has had an opportunity to discuss this latest development further with the FDA and review the Company's options with its medical, clinical and external advisors, it will be unable to provide further comment. Once these details are fully understood the Company will issue the appropriate communication. The Company will hold a conference call to discuss these developments at 4:45 pm (Eastern time) on August 13, 2001. A live audio webcast of the conference call will be available through www.hemosol.com and www.financialdisclosure.ca. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 30 days starting on August 14, at www.financialdisclosure.ca and www.hemosol.com. A replay of the conference call will also be available by telephone from approximately 6:30p.m. (Eastern time) on August 13 through August 20, 2001. To access the replay, dial, 416-695-5800 or 1-800-408-3053 and enter reservation number 880031.<snip>

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