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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: Dr. John M. de Castro who wrote (355)11/17/1999 5:44:00 PM
From: JOEBT1  Read Replies (1) of 666
 
I spoke to IR recently and they said that the FDA wanted to do additional analysis on the data. No additional data was requested. Part of the problem was to get the computer data base modified to enable the analysis. In fact she said that they may be setting a new standard for a data base that the FDA can use for additional analysis. IR said that both management and the scientists are confident that the BLA approval and final approval will be achieved. They admitted that SKB had said that the BLA would be submitted by the end of the first quarter but suggested that they might beat that date. They will be presenting at ASH on Dec 3-7 along with IDEC.
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