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

To: Cacaito who wrote (8422)	1/22/1999 1:17:00 PM
From: aknahow	Read Replies (2) \| Respond to of 17367

Just one minor comment. I don't think anyone implied that the total deaths in and of itself would provide positive proof of statistical significance. To me it meant that at a specified level of total deaths the trial could be ended and at that point statistical analysis would be used to determine if the difference between Neuprex and the placebo was statistically significant. From the start, it has been made clear that XOMA did not want to run a trial that would go for much more than two years because it just did not have the financial ability to do so. From one point of view halting a a specified level of deaths would permit a quick decision as to significance while meeting XOMA's financial constraints. The significance of the information coming from XOMA remains that seeking to accrue additional subjects becomes even less of a concern. Remember, some posters were using the continuation of the trial to insist that this meant that Neuprex was ineffective. If there is a total death level, that must be reached, then this is not necessarily the case. In fact, any reduction in deaths due to Neuprex would result in an extension of the trial. Xoma was at 339 subjects on the 19th. So in any event regardless of which theory is correct, with each day that passes the data becomes more robust. Please take the time to call XOMA, so you can make a final decision on this subject.

To: Cacaito who wrote (8422)	1/22/1999 2:32:00 PM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

Cacaito, this is the way I understand it and I may be totally wrong. First, when Xoma was setting up the trial with the FDA it was centered around time and total death because of money concerns by Xoma and small sample concerns by FDA. It appears the total death requirement has not changed although the enrollment numbers are far more than imagined by anyone. No matter what an interim analysis shows on efficacy, if total death was not reached then no early halt due to overwhelming efficacy. We were led to believe by Xoma that all the interim analysis had to show was overwhelming efficacy, not overwhelming efficacy AND total death number requirement. It is an outrage that total death number was not changed according to surprise increase in patient enrollment. This is where the FDA pound of flesh thinking comes into play. Only my opinions and thoughts, I could once again be totally wrong so call Ellen for yourself.

To: Cacaito who wrote (8422)	1/22/1999 2:33:00 PM
From: Kushi Kullar	Respond to of 17367

I agree. From a statistical point of view there appears to be miscommunication about the relevance of that metric. I am hoping it is a miscommunication and not an early warning of a trial disaster.

To: Cacaito who wrote (8422)	1/22/1999 7:59:00 PM
From: Robert S.	Read Replies (2) \| Respond to of 17367

Thanks, Cacaito, for your informative post. While your proposed scenario is logical, one can not rule out that the trial extension results from the exhibited therapeutic efficacy being marginal. Orphan Drug Status, fast-track designation, trial extension: in toto, George considers the above to be good news; do you? I have to comment on your belittling studies that don't support your views. You were the one who introduced the ABTI trial without caveats. You also demeaned the Lutsar study but have you ever pointed out the flaws of trials that presented BPI in a positive light? Those rose colored glasses are blurring your vision. Glad to see that you too have found value in abstract reviews. My opinions only.