Cell Therapeutics shares are getting a boost today after the company announced that a second independent radiology assessment of data from a clinical trial of the companys antitumor treatment pixantrone confirmed the statistical robustness of the data.
The response and progression endpoint data was previously submitted to the US Food and Drug Administration with the new drug application for pixantrone.
The second assessment was recommended by the FDAs Office of New Drugs as part of Cell Therapeutics
) appeal to the complete response letter it had previously received from the FDA.
The company said it plans on resubmitting the drug as early as next month for accelerated approval, which could provide an FDA action date by April 2012.
Cell Therapeutics had announced earlier in the week that a UnitedHealth Group
) executive, Reed Tuckson, has joined its board.
This year, the company has licensed rights from Chroma Therapeutics to develop tosedostat, and it has an ongoing relationship with Novartis
) for the licensing of Opaxio.
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