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


To: ewolf who wrote (7117)9/2/1998 1:28:00 AM
From: aknahow  Respond to of 17367
 
No, because the Santa Fe conference was not scheduled by XOMA. However if the DSMB does make a recommendation prior to the meeting Dr.Scannon would probably include it in his presentation.

Here are some tea leaves from past comments on DSMB related issues:

What did the September 1997 meningococcemia Phase III interim analysis show? (2/98)
The first interim analysis, announced September 24, 1997 covered the first 65 patients and
included a 60-day follow-up period. The Data Safety Monitoring Board (DSMB) found no safety
concerns and recommended continuation of the trial.

What did the March 1998 interim analysis show? (6/98)
Consistent with our expectations, the DSMB recommended continuation of the trial. They
reviewed an interim analysis of data from 129 patients, and found no evidence to suggest any
safety concerns. They also recommended another interim analysis in September 1998.

What is an interim analysis? (6/98)
Interim analyses monitor the conduct of the study and look for unexpected safety or efficacy
issues. During a trial, the DSMB are the only people that are unblinded to the data (i.e. know
which patients received drug and which placebo). All they report back to the company about results
is that the study can continue, or that the study should be stopped early, because of an unexpected
safety or futility problem, or alternatively, unexpectedly higher efficacy than planned for that
study. Studies are not designed to stop at an interim analysis, but many double-blinded,
placebo-controlled studies have interim analyses in case of the unexpected.

Just because the first DSMB recommendation was made on Sept 24 does not mean this one will be made at the end of the month, nor does the fact that I post this mean it wont.

Really interesting that the company has done so well and the stock so poorly. 252 accrued as of 25 Aug. and at the start of the trials 200 in 2 years was considered doubtful. Also in all the research papers published I have not seen anything that makes me think BPI does not work. Nor do I believe Neuprex will be confined to a niche market.