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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: Vector1 who wrote (157)12/8/1998 8:53:00 PM
From: Bob L  Read Replies (1) of 666
 
Vector1, what is your view of the remarks about FDA filing in the latest press release? On the one hand they announce fast-track status, but then say "With our completed pivotal trial and additional supportive clinical data, we are working closely with the FDA towards submitting the first portions of our Biologics License Application for our I-131 Anti-B1 Antibody to the FDA over the next few months."

This doesn't sound quite the same as submitting by the end of this year, which is what they have said before. It seems to give some support to those who say the phase III didn't provide enough good data.

Overall, the news of late has been great. But I wonder if the timetable has actually slid a bit, despite the fast track status.
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