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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: Cacaito who wrote (9039)3/9/1999 6:28:00 PM
From: Chris Boylan  Read Replies (1) | Respond to of 17367
 
from Cacaito on Mar 9 1999 5:04PM EST

Good post.

> "the DSMB is a creation of XOMA designed to oversee"
> no, it is appointed by the FDA.

This is interesting. I thought this was submitted
for approval along with the phase III design.

> Even if your suspiciousness is right and one have low mortality
> across the range of patients it only speaks good of bpi. Of course,
> one will need more recruits. As long as the DSMB allows the trial
> to continue they are seeing good hope, remember they
> are also bias for good results, they are clinicians and
> they also want a product that works.

That's my point but doesn't it seem like the less likely
of the two possibilities?

As you point out in your recap of the patient enrollment protocol,
this study is suppose to include just sick children and not the ones
that are "too healthy".

If one assumes that the enrollment is succeeding as per plan
and given that enrollment is 80% more than what XOMA said would
be the trial size (260) as of this time last year doesn't it
seem like the most logical explanation is that the mortality
efficacy is bumping along between the target p value and chance?

I actually found the latest press release somewhat hopeful
in that they said:

"With the United Kingdom providing the majority of our patients,
total enrollment has been higher than anticipated, but the
overall mortality rate in the trial has been lower than originally
projected," said Jack Castello...

If you accept this at face value and interpret it literally
it supports the enrolling too many healthy people argument
and I think that's the best we can hope for at the moment.