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clock Created with Sketch. 05/08/16
16:53
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Originally posted by hottuna
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He called it new data, it's not. It's really old data. The peer review involved paying to attend a conference largely populated by anaesthetists, run by a society that apparently shares its offices with a bunch of chiropractors. That's not publication of full data to a proper journal for proper peer review, that's marketing.is recruiting 360 patients across 30 sites in the United States and Australia, randomized 2:1 to receive either 6 million MPCs or saline control. The trial's primary endpoint of Overall Treatment Success (using a composite of 50% improvement in lower back pain and 15 point improvement in function at both 12 and 24 months) is an acceptable endpoint for product approval, as per guidance from the United States Food and Drug Administration (FDA). Subject to further discussions with the FDA, Mesoblast anticipates being able to provide interim data from the trial in early 2017 ."enrollment completion is expected in mid-2016, an interim analysis is expected in mid-2016 and top-line data are expected in mid-2017."
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Correct me if i am wrong,
(20min delay)