Comment from Presentient Technologies Ltd
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Summary: Presentient Technologies Ltd, a biostatistics technology company, supports the proposed pilot program and proposes using its BRAKES system as a primary tool for early futility detection and real-time safety monitoring. They argue that their technology can improve ethical outcomes for participants and increase trial efficiency while maintaining data integrity through a secure, deterministic algorithm.
Presentient Technologies Ltd respectfully submits the attached comments in response to the FDA's Request for Information; AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390).