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Biotech / Medical : PSDV - pSivida Limited

PSDV 1.220

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Mar 29 5:00 PM EST

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From: John McCarthy	12/23/2009 11:06:17 AM
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..... from the press release In addition to the analysis described above, as prospectively planned in the protocol, Alimera also conducted several other analyses of the 24 month data. These included (a) an All Randomized and Treated (ART) analysis of the 24 month data that includes data from all subjects randomized and treated and imputes values for all missing data using the LOCF method and (b) a Modified ART analysis that utilizes the ART population but excludes data collected subsequent to the use of treatments prohibited by protocol (such as intravitreal injections of Avastin, Lucentis or triamcinolone acetonide) with the last observation prior to protocol violation imputed to month 24 using the LOCF method. The results of these separate analyses are described below: ========================= By the ART analysis, ========================= in Trial A (of the ART analysis) 26.8% of low dose patients and 26.2% of high dose patients gained 15 or more letters at 24 months compared with 14.7% of patients randomized to control (p = 0.029 and 0.032, respectively). In Trial B (of the ART analysis) 30.8% of low dose patients and 31.3% of high dose patients gained 15 or more letters compared with 17.8% of control patients (p = 0.028 and 0.026, respectively). The results for both doses in both trials were statistically significant. ========================= By the Modified ART method, ========================= in Trial A 22.6% of patients in the low dose and 24.1% of patients in the high dose gained 15 or more letters compared with 12.6% of control patients (p = 0.057 and 0.026, respectively). Trial A was not statistically significant for either dose. In Trial B by Modified ART, 29.7% of patients in the low dose and 29.3% of patients in the high dose gained 15 or more letters compared with 13.3% of control patients (p = 0.004 and 0.005, respectively). The results for both doses were statistically significant. The FAME study protocol provides that the primary assessment of efficacy will be based on the Modified ART dataset and that the other datasets will be considered secondary; the protocol did not specify the Full Analysis Set as a dataset for analyzing the study. However, we believe that the FDA will consider the Full Analysis Set to be the most relevant population for determining safety and efficacy in Trials A and B. finance.yahoo.com

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