Silicon Investor (SI) -- The First Internet Community

STOCKTALK

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: PrometheusTex who wrote (10015)	5/16/1999 10:05:00 PM
From: Cacaito	Read Replies (3) \| Respond to of 17367

Meningococcemia mortality has not changed, even at best centers. Check posts: 8220,8235,7565,7560. Sepsis mortality has not changed even at best centers. 8599 Biologics do have higher hurdles at FDA. There were no changes "onthe fly". Xoma got more patients in the early shock group (low Glasgow scores) this on itself decrease mortality. But it will not impact on the trial (except for need of more patients), the efficacy of the drug will not changed. 8197, 8206,8216 The trial designed on itself corrects for a decrease in acuity of the disease. Trial was stratified from the start. post to protocol 6523 Early halt was speculation from many, born mainly out of the very good data and efficacy from phase I/II trial, originally a phase I, the FDA accepted to go straight to phase III. M.Murphy was constantly claiming early halt will happen, till it did not. Xoma, to my knowledge did not promoted idea of early halt. They even discouraged it. I remember they told callers to IR that for early halt only ZERO deaths in BPI group would made it, obviously this is not promotion. SI thread was always on speculative mood, each DSMB meeting became a disappointment. Good DSMB post 9068. Xoma did promoted idea of 200 patients and end by Dec 98. For me it was no problem, I used it as guideline, not for enforcement law. link to UK site post 8449. Valuation model 8237, 8240. other sepsis drugs (mostly failures)8398,8403. some speculation on statistics 8197. An expected decrease on morbidity and decrease of sequelae is part of the trial design, and the 90 days follow up is mainly to check for neurological evaluation. If the drug does not decrease mortality I am saying good bye to this one, even if FDA approved. Results similar to the hem/trauma trial will sent the shares to $0.25 at best, company will become a takeover (actually a leftover) target. Off label 6097. summary expect big and quick off label uses. ER and intensive care clinicians are aggressive and innovative and they will use Bpi for septic patients.

To: PrometheusTex who wrote (10015)	5/16/1999 10:18:00 PM
From: Robert K.	Respond to of 17367

I concur, yea R Promethius. Long live promethius. Actually ab better way in retrospect is to just post on yahoo that you are who you are on SI. the reason for all this spy stuff is we must be ever vigilant for the scum amoung us. This also is a subject I have been meaning to broach. We may very well now have mirthie types disguised as longs for their own benefit. One must put more faith in those whom have carried reputations and less faith and some suspicion in the newly arrived. One can easily (with money) use a yahoo handle to come to SI to try to smoke us as a trusted Yahoo'r. (to me anyway PTEX) . Also I might add as ( and if) the stock rises, the risks will rise, as we will have more to lose. I am warning you all now that new longs will come in and try to get us to sell by speading false info. False rumors etc.....We must ALL do Due diligence OURSELVES to not be falsly lead. If this happens do not panic, think, prepare now what you will do under specific circumstances. All IMO. Standard K disclaimers.

To: PrometheusTex who wrote (10015)	5/16/1999 10:31:00 PM
From: aknahow	Respond to of 17367

Think Cacaito said it all. Have comment on :<<< Even scientists that have experience with the FDA and that follow XOMA had hope of an early halt. Has anyone been able to nail down how this hope proliferated and whether the company ever supported the notion? Or were we smoking something?>>>>>> ditto what has already been said. A post by Robert S a copy of FDA procedures, indicated that a DSMB could not recommend termination of a trial if a FDA mandated endpoint had not been met. Since R. S. had been critical of XOMA bulls and often raised doubts about XOMA he was considered non biased in favor of XOMA, so his post carried weight. For me it explained what previously had been impossible to understand, "If BPI is so good why don't they recommend the trial be halted?" Apparently with the pre established mortality requirement not being met they could not recommend a halt. Some try to say XOMA itself could not halt. Of course they could. they don't have unlimited funds and can halt any trial when they want to but then they assume the risk that chances of approval might be diminished. I really doubt the Brits have done so well in reducing the mortality rates. All the citations of mortality rates are non stratified and a bit sloppy. Sort of like post on various boards. Things like mortality ranges from 5% to 50% mean nothing.