When we talk NDA in 2026, we are talking without DMOAD labelling? One of my concerns given the FDA don’t really have any endpoints in regards to proving DMOAD and have left this to PAR to explore, is that we will require another large trial to achieve the labelling. My second concern is that the company won’t allow their darling to go to market without the DMOAD label. Does anyone have any thoughts on this?
research reports and media, page-3513
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