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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (7051)	9/6/2002 3:41:33 AM
From: Doc Bones	Respond to of 52153

Since this is an important and hopeful development, I'll add that the online WSJ appears to carry the identical story, under Chris Adams' sole byline, with the following appended at the end in place of the line: "Wall Street Journal Staff Reporter Chris Adams contributed to this report" Congressional officials were informed of the change Thursday, and were told a formal announcement was imminent. The biologics division will retain many of its functions, including those over blood products, vaccines, gene therapy and tissues. It is expected that the reviewers themselves will be shifting divisions, meaning there won't be new people reviewing applications, according to people briefed on the change. But by blending operations with the larger drug division, the biologics reviews could come to employ many of the same standards as drug reviews. Write to Chris Adams at chris.adams@wsj.com Updated September 6, 2002 online.wsj.com

To: tuck who wrote (7051)	9/6/2002 7:11:23 PM
From: Doc Bones	Respond to of 52153

Thomas Weisel is quick to drop a wet blanket on the story of the FDA switching approval of some biologicals away from biologics to drugs division. [briefing.com] 15:14 ET Thomas Weisel on biotech Thomas Weisel believes that today's announcement that the FDA will switch its reviews of biotech product candidates to the Center for Drugs Evaluation and Research (7:09) will be neutral to the biotech industry and will have no impact on biologics approval times; historically, C.D.E.R. has placed applications under more stringent reviews than the biologics division, which could be negative for some biotech co's, and C.D.E.R. is less apt to view non-traditional approaches to drug development employed by some biotech co's favorably.