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

To: aknahow who wrote (9364)	3/24/1999 6:34:00 PM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

I think with the limited amount of facts and data, Bob, Cacaito and SL have done a wonderful job of explaining things. Can you imagine how these individuals would shine if they had all the facts and data? In my opinion I now think that Murphy might be correct in speculating treated group had no deaths because I don't think it would be that hard to improve on Phase II open label results. Think about the physical characteristics of the young person that died in open label Phase II. Was that only a coincidence that the only one who died had those physical characteristics? What would be the chances of getting another like that in treated arm of Phase III? Once again, only my opinions.

To: aknahow who wrote (9364)	3/24/1999 7:49:00 PM
From: xomadog2	Read Replies (1) \| Respond to of 17367

GW- Pay attention! As I understand the current Meningococcemia trial, was originally constituted as a 135 patient trial. The FDA wanted 200. As the trial progressed and after the first interim the company agreed to increase the trial to a sample size of 200 patients.The trial design calls for an agreed to minimum number of mortality events to be achieved in order to close the accruals into the trial. They have still not reached the min number of deaths needed to complete the number of events agreed to in the trial design, and due to the fact that the rate of mortality is less than thought when,the trial was set up, the sample size has been increased as confirmed in the release by the company to 370,so far. From what I know,the month of March has been a very productive accrual month and the first half of April as well,in the previous 2 years of this trial.This is, an unblinded study.So,what are you trying to figure out that can be backed into with blinded info?- How good the data is? How many more deaths they need? It's rather simple. If they reach the minimum event number in the next 30 days the trial will stop accruals and the company probably will announce that the trial has stopped new accruals and they are waiting to do a follow up and compend the data. It would make sense that the FDA be involved in what ever statement the company wants to make and every decision they make with regard to keeping the trial open or clsoing accruals. Since no one knows how many deaths there are,except for the DSMB, or which arm the deaths are in, and the DSMB have given a thumbs up to futility not being an issue You,along with everyone else will just have to wait and BE PATIENT! With so much going for this compound it s hard to imagine that it does not show efficacy in this trial. Hang in there....