Yes, but if a partner wants more data, we should produce it in a phase 3 trial and why not have a subset of subjects generate this…. now. I’m really happy to see these outcome measurements maintained, even if we are a durable pain and function drug in 2025.
I understand the costs to monitor/apply for DMOAD and the monitoring required would be financially onerous (unless a partner is sitting and waiting to strike once 2mg dose is approved, trial design is re-worked and adrenal misnomer is addressed.) F@CK knows. As KP said, no one knows (except a few that think they do).
It’s a piece of information I’ve been waiting for. This is a big moment.
I wonder if DMOAD label can be attained in Aussie TGA provisional approval?
I also wonder if a subset of phase 3 stage 2 trial subjects are outcome measured for DMOAD, whether that data can be used for accelerated approval, too.
Donna, no doubt working on all this. She is a gun. What would we do without her?
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