XOMA. Bull or Bear? Message Board

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Biotech / Medical : XOMA. Bull or Bear?

XOMA 26.52

+3.4%

3:59 PM EST

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To: aknahow who wrote (11286)	8/17/1999 2:32:00 AM
From: opalapril	Read Replies (1) of 17367

<<it may be that even 12 or 13 deaths in the treatment arm vs 22 or 21 in the placebo do not provide statistical significance>> Perhaps not, IN THEMSELVES. <<but it would IMO still be a very positive sign.>> Agreed. This would be consistent with the analysis you posted earlier. It would also be consistent with Xoma's release statement -- <<Based on its preliminary analysis XOMA believes the data show a clinical benefit in mortality and morbidities, but is scheduling a meeting with the FDA to determine adequacy for filing a BLA.>> As I understand the analysis given at the url you posted, statistical analysis of mortality and morbidity results of an anti-sepsis compound should be understood as far more complicated than any ordinary one-tail or two-tail probability calculation such as suggested weeks earlier by almost everyone. The questions to ask are at least as complicated as the answers sought. Under these circumstances, of course the FDA would want to meet beforehand and settle with Xoma on the details of an appropriate skein of endpoints, exclusions, points in time and treatment, perhaps differing weights to differing clinical settings, etc. etc. etc. Would have been nice if Castello were more of a teacher and had lectured the cc a little on this. Then again, there is this problem of not wanting to ruffle the FDA's feathers.....

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