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Biotech / Medical : Biotech & Pharma.T.A,

BIB 79.90

-4.5%

Dec 1 4:00 PM EST

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To: Jibacoa who wrote (259)	1/31/2003 9:41:48 PM
From: JMarcus	Read Replies (1) of 3722

Bernard, there was news today about FDA initiatives to speed things up: Message 18521538 I received a very long reply to an email inquiry to BPUR. I've requested permission to post it. Based on FDA performance goals and guidelines in the Prescription Drug User Fee Act (PDUFA), BPUR expects the agency to act on the BLA in the mid-2003 time frame. The actual goal set forth in PDUFA for an original standard BLA, once accepted, is 10 months from the submission date, which for the Hemopure BLA would be May 31, 2003. Because Hemopure is a first in its class product, the process may take longer and the FDA may choose to seek guidance from its Blood Products Advisory Committee (BPAC). Too bad for our troops that Hemopure won't get approved before the invasion of Iraq begins. But the heightened awareness of the nation (which should include the FDA) about the perils our military might need to face should give some impetus to expedite the approval process for a product like Hemopure, whose use on the battlefield could save many lives. Marc

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