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Biotech / Medical : Cell Therapeutics (CTIC)

CTIC 9.090

0.0%

Jun 26 5:00 PM EST

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To: tom pope who wrote (509)	3/7/2005 7:55:21 AM
From: Icebrg	Read Replies (2) of 946

>>Put it in the non-binary file?>> For the time being, at least. It's really too early to tell what went wrong, if anything went wrong. If this was just a case of the trial being underpowered, there are another two studies to be unblinded before the half year mark. If there was indeed no treatment effect observed, we can just as well concentrate on Pixantrone in Q4. It's also very difficult to say what to make of the non-inferiority argument put forward by the company. The FDA has approved based on that recently (Abraxane and Alimta). But that is a tricky area, so one should perhaps not hope to much from that. The best hope for longs should be a classic case of too little power to prove the survival benefit. Then there should be a fair chance that one of the next two trials will do better. FDA's statisticians willing. I was pretty confident that there was going to be a positive outcome based on the survival, but I was evidently wrong on that count. Erik

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