Kadmon kicks off 'real-time' NDA submission with another look at 'remarkable' chronic graft-versus-host-disease data
Six months after reporting “knock-your-socks-off kind of results” for its chronic graft-versus-host-disease drug from an interim analysis, Kadmon is back with a final slate of data that it said retained, if not amplified, the wow factor.
The positive topline data have already been sent to the FDA, the company said, as part of a package filed under the Real-Time Oncology Review program. Kadmon expects to formally submit the NDA by the end of this year, complete with a final chunk of 12-month follow-on data.
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