I just read the above article and noticed at the bottom it says SB Cardigan I and II trials used proprietary validated patient-reported outcome, HDSM-Ax score as the primary end point.
Does anyone know what this means?
The reason this comes to mind is because the mid-review cycle announcement mentioned the FDA just had to confirm efficacy and labelling.
I’m wondering if that confirmation of efficacy is somehow tied in with how the outcome was scored / assessed?
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