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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: sammaster who wrote (779)	1/16/2006 2:00:51 AM
From: Icebrg	Read Replies (1) \| Respond to of 946

The company will not file based on non-inferiority claims in the US, which means that they are not able to show this to be the case, according to FDA's criteria. This is in itself not so surprising, as these trials were not set up to prove non-inferiority. In the EU however, CTIC will, according to the company, file claiming non-inferiority. Maybe, I might add, as it seems that they have not yet sorted out with EMEA what is required to do so. Erik