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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Joe Wesley who wrote (334)	9/29/1999 3:02:00 PM
From: bluejeans	Read Replies (1) \| Respond to of 666

thanks for the link.

To: Joe Wesley who wrote (334)	9/29/1999 4:40:00 PM
From: RCMac	Respond to of 666

Updated version of the Bloomberg story: quote.bloomberg.com South San Francisco, California, Sept. 29 (Bloomberg) -- Coulter Pharmaceutical Inc. warned that it won't be able to meet its goal of re-filing for approval of its Bexxar cancer drug in October. . . . . . Coulter shares have fallen 65 percent since the end of August when the FDA rejected the original Bexxar application. In biotechnology, ''execution is of critical importance,'' said Lance Willsey, a fund manager at DCF Capital, which manages about $200 million. ''And here, the execution has been suboptimal.'' . . . Coulter disclosed the delay yesterday when Chief Executive Michael Bigham discussed the issue at an investor conference in New York held by Warburg Dillon Read. Coulter realized it wouldn't meet its October target after it asked the FDA to clarify a request for reformatted data on Bexxar, said Coulter spokeswoman Sylvia Wheeler. The FDA made that request in August when it rejected the original application. She declined to say when Coulter might resubmit the application, saying the company won't be able to make such an estimate until the FDA explains how it wants the data to be presented. ''We're still talking about the same things that need to be reformatted,'' Wheeler said. ''We're trying to get clarity on that to make the database as user-friendly and easy to navigate as possible.'' Troublesome Delays The delays are troublesome because investors had hoped that Bexxar would be the first approved drug in a new class of experimental radioactive treatments for non-Hodgkins lymphoma. The new drugs seek out and attach themselves to tumors, then dose the cancerous cells with radiation. . . . . . While Bexxar may still be on track to beat Idec's Zevalin treatment to market, both drugs are likely to be approved next year and Bexxar's lead is narrowing, said Curtis Hogue, an analyst at Volpe Brown Whelan & Co., who has a ''neutral'' recommendation on Coulter shares. ''I think Bexxar will eventually be approved. The question is just the timing,'' Hogue said. [snip, snip]