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


To: Kushi Kullar who wrote (7889)11/30/1998 3:07:00 PM
From: aknahow  Read Replies (2) | Respond to of 17367
 
The trial requires a 90 day lookback. Without a recommendation from the DSMB this could not be changed. Read what XOMA itself said and draw your own conclusions.

"Neuprex(tm): Meningococcemia

What did the DSMB recommend in September 1998? (9/98)
As expected, they indicated to us that they saw no safety issues and recommended continuation
of the trial. They also requested an additional review shortly before completion of enrollment.

Was this additional review part of the original statistical plan for the trial? (9/98)
The protocol allows the DSMB to recommend additional reviews (as they did in March when
they recommended the September interim analysis). An additional review gives the DSMB the
opportunity to take a final look at the results. If the trial design requires any final adjustments,
we can make them. If the data are sufficiently positive, we can get a head start with the
regulatory authorities."