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Biotech / Medical : Texas Biotech (TXB)

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To: JuniorMint who wrote (530)	1/23/1998 4:11:00 PM
From: Dauntless	Read Replies (1) of 834

Why do you think their way of conducting business is unusual? In the normal parlance of the drug industry, TXB is "developing" this product. I can't find any company statement predicting FDA approval in February. This is a portion of the press release last year that announced the fast-track approval: =================================================================== TEXAS BIOTECHNOLOGY'S NOVASTANr NDA GRANTED PRIORITY REVIEW STATUS BY THE FDA Houston, TX -- September 4, 1997 -- Texas Biotechnology Corporation (AMEX:TXB) announced today that the Company's recently filed New Drug Application (NDA) for NOVASTANr (argatroban) has been granted priority review status by the U.S. Food and Drug Administration (FDA). On August 6th, Texas Biotechnology and SmithKline Beecham announced an agreement to market and co-develop NOVASTANr in the U.S. and Canada as anticoagulant therapy in patients with heparin-induced thrombocytopenia (HIT). In addition to HIT, NOVASTANr is also being evaluated in other indications including use as an adjunct to thrombolytic agents in acute myocardial infarction. "We are pleased the FDA is considering our NOVASTANr NDA for priority review," said David B. McWilliams, President and Chief Executive Officer of Texas Biotechnology. He added, "we would anticipate receiving a response to our filing from the FDA by the end of the second quarter 1998." =================================================================== It's pretty clear about the time frame for approval. I guess I was also kind of hoping for a little earlier word, but this is not bad news. I spoke with the company today and this data only strengthens the case for approval. It seems like forever but I think this is the time when we have to be patient just a little while longer - this one's almost at a boil!!!

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