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Biotech / Medical : Genta, Inc. (GNTA)

GNTA 2.300

+0.4%

Nov 7 9:30 AM EST

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To: tom pope who wrote (1818)	5/25/2004 7:35:42 AM
From: rkrw	Read Replies (1) of 1870

Tom, I'm not sure the question. I found this statistical fluke (or purposeful? :-)) very interesting. So many different aspects of trials need to be carefully stratified so as not to bias an outcome. When you get a close outcome like for genasense it's possible to conclude that a bias like this could be responsible for a good portion of the reported benefit. For a cancer trial, seeing one arm of patients earlier or more often than the other can corrupt the real outcome since, for this case, control group patients could be "progressing" sooner than the drug arm if only because they were following up earlier or more often than the drug arm. Why Genta didn't standardize timing for visits or weren't more diligent in controlling followup visits was a major flaw imo. I think the fda concluded this difference did in fact probably contribute somewhat to the reported benefit of genasense. If the genasense benefit was huge, perhaps this wouldn't have been so much of an issue.

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