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12-19-2013, 10:35 AM | #1 | ||
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Magnate
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http://www.lctglobal.com/html/blob.p...lementId=20084
The withdrawal of the rat efficacy data does not in itself present a safety risk with regard to the use of NTCELL in humans . Nonetheless, as a precautionary measure LCT has placed a hold on any further patient recruitment into the human Phase I/IIa clinical study that is currently underway at Auckland City Hospital. This is to allow the company to work with the New Zealand medicines regulator (Medsafe) and the data safety monitoring board (DSMB) to fully understand the impact of the withdrawal of the rat efficacy data on the Phase I clinical trial |
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