Yes plenty of upside Mozz if all goes according to plan.
My enthusiasm is going to remain in check until such time as the FDA give us a clear pathway to NDA with Or without DMOAD.
I still consider the latter a relative long shot for initial labelling given our consultation own scientific views (Kraus and Felson) to address the clinical challenges. Yes biomarkers are relevant considerations but this means nothing to us unless the FDA are also convinced that the proposed surrogate endpoints are compelling enough in a heterogeneous slow moving disease.
My current expectations would be no Accelerated Approval as it's not immediately life threatening and post marketing approval studies that could extend to up to a decade. I'd also note surrogates endpoints would be a first for OA so expect the FDA to be super conservative.
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