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Biotech / Medical : Cell Therapeutics (CTIC)
CTIC 9.0900.0%Jun 26 5:00 PM EST
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From: Rudy Saucillo3/7/2005 7:30:11 PM
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Sounds like, from the cc this morning, that Bianco and co. at least believe they understand what went wrong with the trial...and will report at ASCO.

Irrespective of these risk factors that confounded the log rank analysis, I simply can't imagine the control arm performing as it did.

STELLAR 2 reports next. Correct me if I'm wrong...isn't this an all U.S. trial??? From the clinical trials database, I see no stratification based on geographic location and no treatment sites outside of the U.S. (i.e., no Canadian sites).

So, if the issue had to do with limited control of international sites, we may not see similar issues in STELLAR 2(?)

Re. the proposed revision to the SPA, my guess is that the FDA will be agreeable to it.
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