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


To: opalapril who wrote (8475)1/25/1999 3:13:00 PM
From: aknahow  Respond to of 17367
 
Opala, I only know of two DSMB meetings in 1998. It is possible there was one in Dec. but this is not certain. The first was:

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

The second was in Sept. Prior to these meetings the previous meeting was Sept.97.

The separate category for, George, did not go unnoticed. You can call me Wohankito.<g>



To: opalapril who wrote (8475)1/25/1999 4:22:00 PM
From: Bluegreen  Read Replies (2) | Respond to of 17367
 
Opal, the dirty little secret which I keep referring to as pound of flesh is us being misled on mortality number requirement. They didn't want the general public to know this fact. Remember the FDA cannot stand sunshine and I think they thought they would be safe with this mortality requirement because it is being extracted from kids without any activist group standing up for them. Speculation on why so many interim analysis meetings could be that maybe some on DSMB were actually trying to change the death requirement because of so many unexpected enrolled.