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Its measurable
The sNDA was based on results from the Phase 3, double-blind, parallel-group, placebo-controlled cardiovascular outcomes trial, SOUL. The trial reported a 14% reduction in the risk of MACE compared to placebo when added to standard of care in patients with T2DM and established CVD and/or CKD
The timeline from data readout to potential approval typically spans 12 to 18 months, depending on whether the FDA grants priority review
Red puncta (mRFP only, representing autolysosomes) and yellow puncta (overlapping of mRFP and GFP, representing autophagosomes) were counted and presented as number per cell
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