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

To: opalapril who wrote (9028)	3/9/1999 2:01:00 PM
From: Chris Boylan	Read Replies (2) \| Respond to 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.

To: opalapril who wrote (9028)	3/9/1999 5:43:00 PM
From: Cacaito	Respond to of 17367

Opalapril, no company will look for tougher standards and not Xoma. Xoma is $300 or so millions down the drain for the last 15 years, Will they look forward for tough? I strongly doubt it. They just plain do not know the results, except for the total mortality, and this just will give you nightmares from guessing. This is plain, just patient. My time limit was 18 months and they are now 20 months. The rule for research is triple the estimated initial time, another 6 to 12 months is just the usual. <<Nonetheless, we believe that we are now close to reaching the specified number, allowing us to conclude accrual with the statistical power called for in our trial design.>> "We believe" is a completely subjective expression. No value for me. "We do know" when I hear this one then I will put more money in.