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Biotech / Medical : XOMA. Bull or Bear?
XOMA 26.09-0.2%3:59 PM EST
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To: opalapril who wrote (10609)7/3/1999 12:17:00 PM
From: aknahow  Read Replies (2) of 17367
 
Forward to the present!

If Mike Murphy is correct, Tuesday will be a great day IMO. He says XOMA was
granted the ability to look at
the P III data after the 60 day look back is over. This is over at the latest on July 13.
While we know from the
BBC that a death occurred on the 13 th. or 12 th. we do not know that the boy was
enrolled in the trials.

I cannot assume that the biotech industry or the FDA is run by idiots. If the data
shows a significant reduction
in mortality for the treated group I have faith that common sense will permit everyone
to find a way to move
the drug through approval faster, even if it takes some darn emergency bill in the
Congress.

Or even in the face of absolute proof that a drug works will nothing be done to speed
up the approval process?

Why permit XOMA to look at the data? Just because they were curious about the
result? Must be some reason.

Yes, I am aware the data might show no positive result for Neuprex of great enough
statistical significance.

Now what does a DSMB do. They monitor safety and can if the rules permit it
recommend a halt for super
efficacy. But as Robert S. (not K), posted, they can not recommend such an efficacy
halt if one of the mandated
end points has not been met.

I do not see that a DSMB does other things such as writing an analysis, or making
recommendations to the
FDA. This type of activity would unblind the data to those that had access to the
report and we understand this
is a no no
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