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Biotech / Medical : XOMA. Bull or Bear?
XOMA 25.33-1.9%Dec 17 3:59 PM EST

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To: Cacaito who wrote (15885)7/16/2002 6:45:42 PM
From: aknahow  Read Replies (1) of 17367
 
Sad, sad, sad! While I recognize that DNA screwed up by not limiting the number of subjects treated with the Xoma produced Xanelim you have no idea about what happened with the request for a complete response. It means a delay and to say BGEN is on track is not correct. It has now been delayed and how long depends on how quick BGEN provides the complete response and how long it takes the FDA to reply to BGEN. Fl Mist is not being subject to new trials. It simply got another request for a complete response after providing a complete response to the first request.

BGEN rushed to file, with trials based not on weight but one dose fits all. They did not have 1.500 subjects but only 1,350. The FDA wondered about both the efficacy and duration numbers provided by BGEN. Nice to know that you accept anything BGEN says without question. BGEN = clone of IMCL/ELN!
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