I am presenting fact as they stand! Vying for EMA approval despite the treding negative opinion are hopes and wishes that have not yet at least changed current facts.
No matter how many words are put around "OLE", it is still an OLE study and what I said remains fact!
Let's also bring in the mAbs facts once again!
Both mAbs had Phase 3 data already in hand when the FDA approved them. The regulatory hook, however, was accelerated approval on amyloid plaque reduction, with clinical Phase 3 data playing a confirmatory or contested role rather than being the sole formal basis for the initial decision.
For EMA it is simpler than for the FDA: when they finally moved to approve one of the anti-amyloid mAbs, they did so on the back of completed Phase 3 clinical data, not just biomarker change.
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