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Biotech / Medical : XOMA. Bull or Bear?
XOMA 30.46+2.2%9:34 AM EST
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To: tom pope who wrote (16060)9/12/2002 7:31:47 PM
From: aknahow  Read Replies (2) of 17367
 
Tom what is meant by resubmission? "After review of the information Biogen submitted to reply to FDA's Complete Response Letter, FDA determined it was a
class 2 resubmission."

After review of the information Biogen submitted to reply to FDA's Complete Response Letter, FDA determined it was a
class 2 resubmission.

Does that mean BGEN submitted a response before and that the last response was deemed to bea class two response that could require 6 months for a response by the FDA.

If approval is a slam dunk one would think BGEN's complete response to whatever was asked could be answered in less time.

Wonder what the issues are. Am sure BGEN, just like Xoma, will tell everyone tomorrow. <g>
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