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


To: Robert K. who wrote (10728)7/11/1999 11:01:00 AM
From: aknahow  Respond to of 17367
 
Robert, my post is related to un blinding the data. Even XOMA has confirmed
Murphy's statement that they
will be able to unblind after all subjects in the trial have reached the 60 day look back
period. XOMA has not
told Murphy they will unblind on July 13 , only that unblinding will occur between
July 13 and Aug. 13.
According to Murphy XOMA has no plans to say anything more to shareholders than
they are going to apply
for a BLA.

Unblinding early carries a cost. The data, for those that have not reached a specific
look back point, is, of
course, not lost. It just cannot be used as part of the application to support drug
approval. Data from these
patients can be used for any points already reached when unblinding occurred.

Robert do you know if, under subpart E, a company is at liberty to decide when to
unblind? Does any
company, understanding the cost in data, have this ability? Not implying that they do,
just that many posters
do not know and it would be of interest to understand this in general.



To: Robert K. who wrote (10728)7/11/1999 11:48:00 AM
From: aknahow  Read Replies (1) | Respond to of 17367
 
Robert, this is what I posted;

<<<<<<
This means the 90 day look back for 370 occurred June 9. All those accrued from
March 9 thru April 13 will
have also completed the 90 day look back period. We also know that from March 9
thru April 13 the accrual rate
was declining, week by week. Would guess that of the 25 accrued from March 9
thru April 13 about 2/3 of the
25 were accrued with 1/3 or only 8 in the final month. Say even 10, this would still
mean 15 more could be
added to the 370 to produce a total of 385 who probably completed the 90 day look
back period by July 13.>>>>>>>>

These look back periods exist. What the subject data revealed at these points is available
only at un blinding.

Since a total of 395 patients were accrued, I was pointing out that only 25 of them were
accrued between March 9 and May 13 when it was announced that the trial was
concluded. We already know that XOMA has the ability to look at the data once all
subjects have passed the 60 day look back point.

I contend none of us know if XOMA or any company has the ability to unblind a trial before all look back points have been reached.
XOMA apparently does not intend to un blind on 13 July, according to Murphy.
XOMA has said it will unblind sometime between July 13 and Aug. 13.