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Biotech / Medical : XOMA. Bull or Bear?
XOMA 27.23+3.2%Jan 7 3:59 PM EST

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To: tom jones who wrote (3885)9/24/1997 3:53:00 AM
From: Webhead   of 17367
 
I think that it's very unlikely that the DSMB will halt the trial early. They would require truely extraordinary and highly statistically significant data to let a completely new product into the market (which we all know may be used 10X as much off label than on meningococcemia). Since we don't know the criteia used for determining effacacy (other than death) it's a little hard to say at what point you would be expected to reach the >95% confidence level. Given that death is relatively infrequent, a small study of 65 kids may just not be enough to generate reliable data.

If the DSMB votes to continue the trial I would not see this as anything unusual or casting a poor light on BPI, rather it IS the expected result. If other criteria are also examined (amputations, days in hospital liver function or whatever) it is possible that enough positive results will encourage an early halt of the trial.

Ed
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