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


To: Cacaito who wrote (8601)2/3/1999 2:37:00 PM
From: opalapril  Read Replies (1) | Respond to of 17367
 
<<There will not be 15% mortality in the placebo group, forget that.
If there is then Xoma should patent the placebo and forget about Bpi.>>

Great idea, Cacaito. How about a Xoma subsidiary or tracking stock, say, Placebo-dot-com? (Symbol: INRT)

We could issue an IPO at $30 a share, start a double-blind study measuring a new investigative compound which we will name Nostrum®©™, against a naturally occurring substance produced by the human body, say, spit, which has been chemically altered with, umm, ahh, Doublemint gum. Of course, we first issue 46 breathless press releases about new patents, then telephone the saps who bought the IPO and ask how many shares they own while we privately place the shares we retained for ourselves with some offshore investors. Once that's over, we pack up and move to Bermuda, then go short before the P-3 results are released.

Trouble with is, reaching the number of patient deaths required by the FDA could take awhile.



To: Cacaito who wrote (8601)2/3/1999 4:53:00 PM
From: aknahow  Read Replies (1) | Respond to of 17367
 
From an e-mail I understand it really was two arms. the treatment arm was stratified by place on the Glascow scale. 8-11 and 12-15. I suppose that the results are then compared to those who fell in either area in the placebo arm. I think the trial would have gone on forever if they needed to get 116 in each of the two different scale areas.

Now I agree you are probably right about the mortality rate remaining high in the placebo arm, but it is more conservative to assume some reduction given various statements made in the U.K. about reducing mortality by 50% when treatment is provided quickly. These statements were unsupported by data, and I did not place much weight on them. But I can't ignore them either.

If mortality is still 20% in the placebo group and they had trouble reaching whatever the mortality target was then this is very bullish. for this reason I think it is better to temper ones bullishness by assuming some reduction.

Now even though I seem to have been unable to convince you that there was a Mortality target, there was one. And if the original thoughts about the trial by XOMA and the FDA thought around 200 subjects were needed I think one can construct a logical range for the target. 35 at the low to 45 at the high range fit with various mortality assumptions for the placebo arm combined with the treatment arm.

I am trying to help you see why they must be close and why recruitment probably will not continue to 450. Call Ellen. Two arms, not three but you are correct about stratification of the treatment arm.



To: Cacaito who wrote (8601)2/3/1999 9:33:00 PM
From: aknahow  Read Replies (1) | Respond to of 17367
 
Curlyjackito post is interesting. What I don't understand is why a 95% confidence level is required. If the data showed in a total of 350, for example that 10 of the treated died and 30 of the placebo group did not, I would want my kids treated even if the statistical level of confidence was 50%. Am I wrong on this or is it that the above example would be at a much higher level of confidence.

What I am trying to say is why such a high level of confidence required for a life or death disease?