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Biotech / Medical : Biotech Valuation

CRSP 56.77

+1.0%

3:43 PM EST

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To: Ian@SI who wrote (20640)	7/27/2006 9:53:42 PM
From: Miljenko Zuanic	Read Replies (1) of 52153

This came day before AZN release 2Q-report. Does anyone know did AZN say anything about SAINTII today? Trial is enrolled bit ahead, and data may be available by year-end. RNVS is cheep if drug work, but it is expensive if does not. AZN did modify way to do NIHSS analysis, so WHO KNOWS???!!! From RNVS: <<Based on consultations with the U.S. Food and Drug Administration, or FDA, we believe that replication in SAINT II of the statistically significant result in SAINT I on the primary endpoint, measured using the mRS, would be sufficient evidence of efficacy. Based on its review of the SAINT I data and subsequent consultations with the FDA and leading stroke experts, AstraZeneca is making the following changes to provide added assurance that the ongoing SAINT II trial with NXY-059 will build on the success of SAINT I by: increasing the planned enrollment to 3,200 patients from the originally planned 1,700 patients; pre-specifying reduction of ICH in tPA-treated patients as an endpoint; and modifying the statistical analysis of the endpoint of neurological impairment measured using the NIHSS.

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