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Biotech / Medical : XOMA. Bull or Bear?
XOMA 25.65+2.6%3:59 PM EST

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To: aknahow who wrote (9020)3/9/1999 12:16:00 PM
From: Chris Boylan  Read Replies (2) of 17367
 
> from george wohanka

> Since the trial was not stopped earlier or now because of
> futility, we know Neuprex is producing a favorable result.

While I largely agree with everything you said on this one point
I would differ somewhat. You can not assume that Neuprex is
producing a favorable result because the study is continuing.

It might be, for example, they have accumulated 34 deaths to date.
17 in the control group, 15 in the Neuprex group. And two
months ago it might have been 13 in the control group and 15
in the Neuprex group. Neither snap shot would be meaningful
if statistically they need 45 overall deaths, given the
size of the trial, to have a p value acceptable to the FDA AC.
[These numbers are completely bogus obviously and are for
illustration purposes only.]

> Wonder if the DSMB was even asked if the target can now be
> revealed? I would respect a logical reason for not revealing
> the target.

This is an area where I think there has been a little spin control
(and rightly so) on the part of XOMA. The important underlying
point here is that XOMA designed the phase III trial, not the DSMB;
the DSMB is a creation of XOMA designed to oversee the trial
within the guidelines established by XOMA as an impartial entity
not subject to any outside interests. I'd bet money (sort
of already did) that XOMA explicitly decided up front not
to release any results on an interim. What if they LOOKED
bad? They wouldn't be statistically valid and the stock would
still tank. It would complicate their raising cash periodically.

As an aside, one thing I realized last night was that they MIGHT
be getting patients enrolled that are too healthy and instead of
the supposedly "normal" 20% death rate in the control group
they reported in the phase I/II maybe they are seeing (say) 8%.
This would be bullish as it would just mean they completely screwed
up when they estimated the required trial size but that the
results might still somewhat mirror the phase I/II results.

I've been worried for the last 6 months that the study problem
was that there was statistically insignificant spread in the
death rates between the two groups.
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