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

To: opalapril who wrote (8605)	2/3/1999 9:11:00 PM
From: aknahow	Respond to of 17367

Interesting post on Yahoo. Sure everyone saw it but reposting here because it mentions someone I am fond of. BTW also mentions Ellen.<g> Call with Ellen by: Curleyjack 4960 of 4960 Spoke with Ellen Martin this morning and I'll try to convey the sense of the conversation. 1. There was a total deaths target number from the beginning of the mennig. trial or at least from the addition of the UK sites because it soon became apparent that the original study was "underpowered." I was concerned that with a total deaths target it would have been impossible to get an early halt after one of the interim analyses. Ellen said stopping at an interim analysis could have been possible but only with "spectatcular" results. 2. The mennig. trial consists of 2 stratified groups (GMSPS 8-12 and GMSPS 12-15). Ellen was careful to point out that a stratified group is different than a subgroup. Statistical significance is determined first by looking at the study group as a whole and then at the stratified groups separately. These groups were set up prospectively which gives the study its required respectibility. She advised the FDA dislikes after the fact analysis and has required further trials to confirm such an analysis. 3. She advised that the preliminary study in the mennig. trial did not exclude patients close to death (my mistake) as it does in the final protocol but that duplicating that overwhelmingly favorable data will be difficult in the current trial. If at the end of the mennig. trial the primary endpoint is not statistically significant(goal is 95% certainty) then meetng the secondary endpoint may be enough to obtain FDA aproval. The secondary endpoint in this trial is morbidity measured by standard pediatric scales. There is a 60 day follow-up physical assessment and a 90 day follow-up neurologic assessment. 4. It is true that XOMA has the inherent power to stop the mennig. trial(or any trial) at anytime. Management seriously considered ending the mennig. trial at the end of December. It did not for several reasons. One reason was that the target number for total deaths was not reached and it wanted "more robust" data. Management is well aware of the time and expense of going back and confirming data. A second reason was that a complete halt in the trial would have put patients in the study at risk. 5. Ellen still expects the DSMA to meet this quarter. Before that is done XOMA must accomplish several tasks. One is to meet with the FDA prior to the meeting with the DSMB to get permission to continue providing Neuprex to everyone at the study sites on an open label basis. Then scheduling the DSMB is necessary at which point everyone is hopful the trial will end. She believes we have now reached our target death number. She especially wanted to advise Wohanka that the end of the trial will be announced as soon as possible thereafter - no trick definitions of "end." At that point XOMA will have a rough mortality number and that after analysis she is hoping that the 95% certainly goal will be met, but, in any event, all of the data will be analyzed and that if favorable XOMA will push for expedited approval. These were her answers to concerns of mine. I hope I relayed the information accurately. If you have questions contact Ellen.