SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: JOEBT1 who wrote (6776)7/23/1998 1:54:00 PM
From: aknahow  Respond to of 17367
 
No, I did not know this. I am not sure I like this, if it is indeed correct. I was totally under the impression that no XOMA employee was aware of the unblinded data.

Thanks for the info.

From the FAQs:

"Double-blinded" means that
neither the treating physician nor the sponsoring company knows which patients receive the drug.
We will not know which patients received Neuprex(tm) until after the trial is complete and the data
are checked and verified.

Even though the meningococcemia pivotal study is double-blind and placebo-controlled,
there must be some positive signs in the overall test group. Are there any signs that the
drug is working? (6/98)
In double-blinded trials neither we nor the doctors treating patients know who received
Neuprex(tm) or placebo. One of the reasons for double-blind trials is to avoid speculation about
results.

What is a DSMB? What do they do? (2/98)
A DSMB (Data Safety Monitoring Board) is an independent body of medical experts, chosen by
XOMA, who review data from the clinical trial at increments during the study. They do not
normally reveal study data to XOMA nor to other parties, including the FDA. The DSMB may
advise the sponsoring company about study administration, possible safety issues or unexpected
efficacy results."

I find it hard to understand how any XOMA employee would fit in the above. But I believe JOEBT1



To: JOEBT1 who wrote (6776)7/23/1998 6:29:00 PM
From: aknahow  Respond to of 17367
 
Apparently if you are correct XOMA has hired one of the Yahooligans to avoid any conflict in the following statement.

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)