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    Luis Santos • H.C. Wainwright & Co., LLC

    Luis Santos's questions to Compass Pathways PLC (CMPS) leadership

    Luis Santos's questions to Compass Pathways PLC (CMPS) leadership • Q2 2025

    Question

    Luis Santos from H.C. Wainwright & Co., LLC asked about the progress of strategic collaborations with interventional psychiatry centers and the feedback received regarding their readiness to deliver COMP360 if approved.

    Answer

    Chief Patient Officer Steve Levine stated that ongoing collaborations with a broad range of mental health providers, including existing SPRAVATO centers, confirm that COMP360 can fit directly into the current infrastructure. He expressed high confidence that the existing network, including room setups and staffing, is ready for COMP360 delivery upon a potential approval.

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    Luis Santos's questions to Harmony Biosciences Holdings Inc (HRMY) leadership

    Luis Santos's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q4 2024

    Question

    Luis Santos, on behalf of Patrick Trucchio, asked about the Pitolisant GR formulation, inquiring what data points from the upcoming bioequivalence study would support a regulatory submission and confirming the timeline for a 2026 PDUFA date.

    Answer

    Dr. Kumar Budur, Chief Medical and Scientific Officer, confirmed the pivotal bioequivalence study will start in the current quarter with top-line data expected in Q3. He explained that the study aims to show standard bioequivalence (80%-125% range for Cmax and AUC) and reaffirmed that the program is on track for a 2026 PDUFA date.

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