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Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?


To: Marshall who wrote (539)1/26/1998 2:37:00 PM
From: X. Fang  Read Replies (3) | Respond to of 834
 
Report from Lehman Brothers on 1/23

* Texas Biotechnology will release data today from a follow-up study (n=174) of its lead product Novastan in HIT. These data are more compelling than the Phase 3 data and will be submitted for inclusion in the NDA currently on file at the FDA.

* These statistically significant data demonstrated an improvement in the overall composite index to 30% (p<0.001) vs. historic controls (with no increase in bleeding) as compared to 20% (p=0.001) as seen in the Phase 3's.

* Further, if one were to assess the more specific thrombotic composite', the new data suggest a 66% improvement (p<0.001) from historic controls versus 55% (p<0.001) in the Phase 3's.

* The addition of this data set into the standing NDA may in-fact delay the ultimate approval of the product up to 90 days, thus moving the expedited review deadline from February to May, however this provides a higher assurance of approval.

* We view this event as a clear positive for Texas Biotech and its shareholders and continue anticipate a mid-year product launch as we always have. Accordingly, our 1-Buy rating is reaffirmed. ------------------------------------------------------------------------------ BUSINESS DESCRIPTION: Texas Biotechnology Corporation is a biopharmaceutical company engaged in the discovery, development, and commercialization of synthetic small molecule drugs to treat cardiovascular diseases. ----------------------------------------------------------------------