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


To: Tharos who wrote (11292)8/17/1999 8:31:00 AM
From: Arthur Radley  Read Replies (1) | Respond to of 17367
 
Considering the comments offered in the Bloomberg report and the recent sequence of events they leave me baffled. It was my understanding that only in the last week or so the(1) unbinding of the data was started..(2)from comments reported here on SI Ellen Martin was quoted as stating they were TRYING to set a meeting with the FDA(if I recall there was discussion about it being vacation time for FDA officials)
Now it appears that the FDA has been looking at data and may be ready to "pull the plug" on Neuprex. What gives that allows the FDA to make such hasty reviews of data in which now XOMA says they need more time to review the data. If this is the scenario....XOMA wanting more time and FDA already questioning data...FOLKS there AIN'T no middle ground in this issue IMO.

One more thought....In the news release in the first line of the comments on NEUPREX it states...."the company is in the process of analyzing data from the Phase III pivotal trial...".

This only leads me to question again ....why were we told only recently that XOMA was "trying" to arrange a meeting with the FDA and now we find they have reviewed data and "still" XOMA is operating on the basis of still analyzing data. Wouldn't it make more sense to complete the review before you submit it to the FDA, so that you can answer their questions.

Dammit! Someone should get their story together.



To: Tharos who wrote (11292)8/17/1999 9:29:00 AM
From: aknahow  Read Replies (1) | Respond to of 17367
 
I did not say it was great. It is a positive sign only that we now know both deaths and amputations were lesser in a consistent manner during the trial. consistent might mean that from start to finish this was the case and they were not higher for a long time and then finally came in lower.

Positive because we are looking at a fatal disease and a lower level of significance might come into play. As I have posted before I do not see off label use being that great without dramatic conclusive results.