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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: Sam Citron who wrote (531)	3/7/2005 2:01:20 PM
From: Icebrg	Read Replies (2) of 946

No, there will be no need and there is no money for new trials. CTIC's strategy now appears to be two-pronged. 1. Try to convince the FDA to amend the SPA for Stellar 2 (?) to allow for a non-inferiority primary endpoint. 2. File for a non-inferiority label based on the results from Stellar 3 and/or 4. There is of course still a possibility that Stellar 2 and/or 4 meets its original endpoint. It is however impossible to have an opinion on how likely this is, as long as we have no idea if there was a trend or not towards superiority seen in Stellar 3. Erik

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