The trial protocol will probably have to be discussed in some more "collegial" meetings with the FDA, then finalised. We know what happened when SI went ahead with the aGVHD001 trial without checking back with the FDA that he'd actually got it right.
With luck the protocol will be finalised in 12 months or so, and then the participating centres can be trained and recruiting started early CY2025, trial completion date likely end of 2026 and read out 2027. Then fingers crossed it will show efficacy. Will Oaktree wait that long before taking seizing control of the company?
Cell Therapy News/Articles, page-17164
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