Despite Paradigm's trial utilizing anadaptive Phase 2/3 design,and theirNovember 2021announcement of FDA clearancetocommencePhase 3in the US1, followed by Dr. Mukesh Ahuja'sMay 2022 statement that the “First US and Australian subjects [were] dosed in thePhase 3study in knee OA,”2investors have since observed a series of later announcements in2024 and 2025regarding FDA protocol reviews and ethics approvals. This apparent sequence of events, where initial dosing occurred years before more foundational 'readiness' confirmations for the pivotal Phase 3,could lead to questions at the upcoming Annual General Meeting on May 29th about whether these communications were purposelymisleadingto investors.
1) https://app.sharelinktechnologies.com/announcement/asx/b121478233839d867095606cd32ba4db
2) 2) https://paradigmbiopharma.com/wp-content/uploads/2022/06/PPS-for-Knee-OA-BA-2022-16MAY2022-Final.pdf(page 4)
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