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


To: opalapril who wrote (8409)1/21/1999 7:41:00 PM
From: Arthur Radley  Respond to of 17367
 
O ONE TO WHOM BPI WAS
ADMINISTERED HAS DIED.
That couldn't be the answer because I own stock in XOMA and I haven't been that lucky, lately.(:>>)



To: opalapril who wrote (8409)1/21/1999 8:48:00 PM
From: William L. Molair II  Read Replies (2) | Respond to of 17367
 
I debated about posting the following info earlier (I didn't clearly understand Ellen's comments). So, beware of the following's accuracy.

The Phase III trial was designed based upon an endpoint of total number of deaths - because the disease is pretty rare and they did not think that they could get a large enough participants to be statistically significant. This was agreed to by the FDA.

OK I said it. I do not understand it; but it made a lot of sense to Ellen. Again, I was not real clear on this part of our conversation, and it may be inaccurate. So call Ellen.



To: opalapril who wrote (8409)1/22/1999 10:58:00 AM
From: aknahow  Respond to of 17367
 
You said, or were posting your thoughts:

"Assuming the criticality finding is based on the real threat of death from meningo, if the P-3 has been extended
because the total death rate has slowed, as many suppose, because of better diagnosis and nursing care, doesn't
that undercut the finding about criticality that got us the orphan drug status?"

Answer: No. If there are fewer deaths the drug becomes even more of an orphan drug. If death rate for a small number of cases was 20% and better treatment reduces it to 10% there is even less incentive to produce a drug for this indication alone.

You also posted:

"..the delay is due to the fact that NO
ONE TO WHOM BPI WAS ADMINISTERED HAS DIED."

The death rate would not have to be reduce to zero to prolong the trial. any efficacy, even efficacy not sufficient to gain approval would by having reduced deaths below expected deaths would extend the trial.

Remaining cash is a concern for almost every biotech, that does not yet have earnings. If the trial is successful there should be a better chance of financing on more favorable terms than in the past. And indeed a successful trial may get partners to agree to deals that a mutually beneficial rather than one sided.

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