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Biotech / Medical : Biotech vs. Shorts

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To: LLCF who wrote (190)	8/27/1999 1:36:00 PM
From: Biomaven	of 427

Here's CLTR responding to this issue, quoted in a SmartMoney article linked on the CLTR thread: Coulter's naysayers suggest that the company could be in for a big jolt if the FDA decides that it hasn't submitted enough clinical-trial data. In particular, they say, the FDA may demand more information regarding Coulter's contract-manufacturing facilities since it used three different companies during its clinical trials. Michael Bigham, Coulter's chief executive officer, says there's no reason to worry. "We provided the FDA with all the information it needs, all that it asked for," he says. Bigham says the company conducted rigorous trials and proved that all the data it submitted were accurate and that the output from the different manufacturing sites was identical. As soon as we hear what the FDA has to say, we'll let you know if Acampora's luck is still holding. Market presently isn't agreeing with Avalon's view. <g> Peter P.S. I couldn't resist jumping in to the BCRX thread I linked to recently - check out Rick's follow-up as well. Message 11084513

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