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Biotech / Medical : XOMA. Bull or Bear?
XOMA 25.66+2.8%Jan 30 9:30 AM EST
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To: Bluegreen who wrote (9024)3/9/1999 1:41:00 PM
From: Chris Boylan  Read Replies (1) of 17367
 
> To me, once again, senseless rambling but perhaps a feeble
> way to shroud your agenda to spread false information? DUH,
> now why would DSMB say continue trial if your supposed scenario
> was true?

Because the phase III is not statistically valid yet nor has
it become "blatantly obviously", i.e. satisifies a specific
set of criteria established before the trial began, that Neuprex
is ineffective as a treatment for meningococcemia.

Clearly XOMA designed the study to give Neuprex the maximum
chance for success so they won't have included criteria to
terminate the study unless it was abundantly clear that there
was absolutely NO point in continuing.

You could readily imagine (and I assume they did!) that they
crafted a set of criteria such that if there was any possible
remaining outcomes where the drug would likely be found approveable
by the FDA AC that the study would continue even if the primary
end-point, reduced mortality, was a failure.

Now, I can't remember seeing anything about the morbidity results
from the earlier phase I/II so I don't know if that's realistic
or not in this phase III. [If anyone could shed some light on this
point I'd appreciate it.]

When one reads in the meningococcemia FAQ or a press release
that the DSMB did not find any "unexpected safety or efficacy
issues" that doesn't necessarily mean that early-on they
had enough data for an efficacy analysis. It just means that
if they did they would at that point.
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