The PRAC evaluates the safety profile of the drug, and CHMP continues to evaluate quality and efficacy based on AVXL's responses to the LoQ they received during clock stop one. If AVXL failed to respond adequately, or if their responses triggered other questions, CHMP will include these on the LoOI (list of outstanding issues) that triggers a clock stop two by Day 180. So efficacy, proof and magnitude of benefit and data integrity are still being reviewed. It's still possible (and maybe probable for a novel ALZ drug) to trigger a LoOI on Day 180.
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