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Biotech / Medical : XOMA. Bull or Bear?
XOMA 25.710.0%Jan 27 3:59 PM EST
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To: opalapril who wrote (9028)3/9/1999 2:01:00 PM
From: Chris Boylan  Read Replies (2) of 17367
 
message from opalapril:
> Does anyone else remember last Fall when Xoma announced the DSMB
> had continued the trial (hard to keep track, there have been so
> many, but I think that was the second time) and Xoma dropped
> a little statement about the DSMB planning to meet again in
> December, among other things to consider a "redesign" of
> the P-3 trial?

Do you have a reference to this? I don't remember reading this
and I didn't see anything in a quick scan of the faq.

> There were some who asked at the time what on earth could
> that mean? Now I see Mr. Castello or his ghost writer
> (our friend RobertK1, perhaps) seems to be using
> the same phrase, "trial design" to refer to a specific
> "statistical power." Do you suppose that in addition to the
> total body count Xoma agreed in advance to some
> sort of minimum statistical ratio for Neuprex to be determined
> a success?

This is called a p value and measures statistical significance.

Basically, it's a measure of how likely the same results would
have been obtained as a matter of chance.

> Would such a thing be common? Ever used? Sane? If so, what
> could such a ratio be??

It's always used. In designing a phase III trial and getting
it approved by the FDA you always are trying to achieve a specific
p value. The last time I talked to Ellen Martin she told me what it
was for this trial but I can't find it.

Because of the nature of the illness and the lack of an effective treatment the FDA agreed to let XOMA shoot for an easier target
than usual.
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