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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?

To: JMarcus who wrote (258)	1/31/2003 2:36:30 PM
From: Jibacoa	Read Replies (1) \| Respond to of 3722

<<When would you expect FDA's verdict? Late July or early October?>> Marc: Lets hope that the changes that are reportedly being instituted at the FDA will speed up things some.<g>(I otherwise don't have any idea when their decision will come) The company was in recent talks with the FDA in regards to their concerns about the manufacturing facilities for Oxyglobin and apparently this issue has been resolved as the company announced, and they are planning on resuming shipments to US veterinary clinics and hospitals. There is no question that the approval of Hemopure is much more important to the company. It received approval for its use in Africa in 2001 and if the FDA approves it for use in the USA will be good news indeed for the company. Bernard