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


To: Bluegreen who wrote (9024)3/9/1999 1:04:00 PM
From: Webhead  Read Replies (1) | Respond to of 17367
 
Hey lighten up BG! Just because someone isn't spouting the party line on this board don't jump on them and suggest hidden agendas. I too am worried that the trial just keeps on going and going and going. My perhaps mistaken understanding of the DSMB function is that they only stop a trial if safety concerns arise or there is a terriffic response rate. If (God forbid) BPI isn't reducing mortality relative to the placebo group then in the absence of safety issues the DSMB would not stop the trial. From the limited data we have I can only conclude that overall mortality is much lower than expected and that BPI can't be working great (like in the PII) or the trial would have already stopped. This is not to say that BPI won't be approved or offer a tremendous theraputic advantage but we have to stop relying on the PII results as an indication of efficacy since if BPI were still working that well the trial would have already been stopped.

BTW BG, I've been long Xoma for a few years so don't waste your time trying to dismiss my justifiable concerns by claiming that I have some hidden agenda. Besides, with my broker (and I'ld assume for the vast majority of people who read this board) you can't even short a stock as low as Xoma is now.

Ed



To: Bluegreen who wrote (9024)3/9/1999 1:05:00 PM
From: opalapril  Respond to of 17367
 
<<a feeble way to shroud your agenda to spread false information?>>

That was unfair, Bluegreen. I imagine all of us have such anxieties and if we don't we ought to. It would be dishonest to deny it. After all, the fundamental reason a P-3 is required is that there is no reliable evidence any compound works as anticipated/hoped for until a valid scientific experiment produces statistically meaningful results. To deny the possibility of failure is imprudent, self-delusional, and idiotic for a biotech investor.



To: Bluegreen who wrote (9024)3/9/1999 1:41:00 PM
From: Chris Boylan  Read Replies (1) | Respond to of 17367
 
> To me, once again, senseless rambling but perhaps a feeble
> way to shroud your agenda to spread false information? DUH,
> now why would DSMB say continue trial if your supposed scenario
> was true?

Because the phase III is not statistically valid yet nor has
it become "blatantly obviously", i.e. satisifies a specific
set of criteria established before the trial began, that Neuprex
is ineffective as a treatment for meningococcemia.

Clearly XOMA designed the study to give Neuprex the maximum
chance for success so they won't have included criteria to
terminate the study unless it was abundantly clear that there
was absolutely NO point in continuing.

You could readily imagine (and I assume they did!) that they
crafted a set of criteria such that if there was any possible
remaining outcomes where the drug would likely be found approveable
by the FDA AC that the study would continue even if the primary
end-point, reduced mortality, was a failure.

Now, I can't remember seeing anything about the morbidity results
from the earlier phase I/II so I don't know if that's realistic
or not in this phase III. [If anyone could shed some light on this
point I'd appreciate it.]

When one reads in the meningococcemia FAQ or a press release
that the DSMB did not find any "unexpected safety or efficacy
issues" that doesn't necessarily mean that early-on they
had enough data for an efficacy analysis. It just means that
if they did they would at that point.