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SiG

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Alias Born 06/20/2007

SiG

Re: Talc Moan post# 37509

Thursday, 10/15/2009 9:05:38 PM

Thursday, October 15, 2009 9:05:38 PM

Post# of 58465
To me this is the most important fact of this study. This is what got me to invest so much.

However, the primary endpoint of overall survival approached but did not quite reach statistical significance (P=0.077). Subsequently, our analysis of this trial showed that there was a significant treatment interaction effect related to levels of a blood enzyme known as LDH. When this effect was analyzed by treatment arm, survival was shown to be significantly superior for patients with a non-elevated LDH who received Genasense® (P=0.018; n=508).

This tells me that to be approved by the FDA they require a P=0.077 or less. Well, we achieved a P=0.018 on patients where the biomarker (low LDH) was used to seperate patients. Correct me if I'm wrong but I think all the people taking part in the current trial are low LDH. Would this not lead you to believe that there is no doubt positive results will be achieved?
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