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Biotech / Medical : PSDV - pSivida Limited
PSDV 1.220+14.0%Mar 29 5:00 PM EST

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To: John McCarthy who wrote (257)12/23/2009 11:24:58 AM
From: John McCarthy   of 421
 
The month 24 analysis using the Full Analysis Set in Trial A demonstrated statistical significance with 26.8% (p value 0.029) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 26.0% (p value of 0.034) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline. In Trial B, the month 24 data demonstrated statistical significance with 30.6% (p value of 0.030) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 31.2% (p value of 0.027) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline.

The Full Analysis Set includes all 956 patients randomized into the FAME Study, with data imputation employed using last observation carried forward (LOCF) for data missing because of patients who discontinued the trial or are unavailable for follow up. (This data set is commonly referred to as the "intent to treat" population.)

sunherald.com
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