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Post by bthomas55ep on Feb 28, 2024 7:17:10 GMT -5
Anybody that listened to the earnings call hear the question and Mike's response to the Phase 3 Clofazimine trial design. I understood that Japan might need to confirm a different result for their purposes, but that they introduced a certain risk to the outcome and the analyst felt it to be somewhat unusual. Does anybody have a take on what the situation might be? I don't have enough knowledge of trial design to understand what was presented. Thanks. GLTA.
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Post by prcgorman2 on Feb 28, 2024 20:58:13 GMT -5
I may have misunderstood, but what I got out of the question and answer was that the FDA required (or at least strongly recommended and, well, they're the folks evaluating for the purposes of regulatory approval) that Patient Reported Outcomes (PRO) be a co-primary endpoint for ICoN-1 Ph3 Study design. Mike emphasized MannKind didn't think PRO should be co-primary, and mentioned that the Japanese didn't require it. All that said, I have no idea what all that means. And, I might be misrepresenting it. Caveat Emptor. (FWIW, if you skip to Mike's overview of slide 16, you'll hear some of the story, and then you can go back to the Q&A and perhaps make more sense of it.)
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