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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1007

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  1. 6,110 Posts.
    lightbulb Created with Sketch. 2162
    Hey, does anyone remember that randomised, doubleblind trial with a couple of hundred Covid ARDS patients, where half of them got doses of Remestemcel to match the dosing used with GVHD?

    Wonder if they had any assay data from that trial that they were able to share with FDA in relation to the GVHD application.

    Just thinking out loud.
 
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