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Biotech / Medical : Introgen Therapeutics

INGN 7.020

-2.9%

3:59 PM EST

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To: Jibacoa who wrote (455)	12/22/2005 4:16:01 PM
From: tuck	Read Replies (1) of 802

I'm having trouble getting my head around this and the implications, so I'll take any help. They presumably pay a statistical penalty in unblinding the results for interim analysis, and since they are short of the protocol specified enrollment, one would think they wouldn't have power for statistical significance, i.e. p numbers that we like to see. Nevertheless, the FDA is apparently encouraging them to do this. I'm not sure what Sobol means by "We have enrolled adequately for the number of survival events to have occurred" in this context. Apparently there is a substantial subset that can be quantified by "prognostic factors and the disease characteristics that define the patients most likely to benefit from ADVEXIN treatment." I guess we have to wait for the actual interim results to show up to find out what that subset is. Perhaps Zeta knows, based on studies posted here. I've not followed closely enough of late. The stock finished up only mildly. Cheers, Tuck

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