Comment from DrKumo Inc.

DrKumo Inc. submits this response to the FDA's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). DrKumo Inc. and the Baim Institute for Clinical Research have partnered to provide these joint comments on the proposed pilot. The questions FDA has put forward get at something we work on every day: the stretch of time between scheduled visits, where safety signals first appear and where trials quietly lose weeks. DrKumo is a connected health technology company based in Anaheim, California. Its technology collects continuous physiologic and objective data from patients at home using FDA-cleared monitoring devices (blood pressure monitors, glucose meters, pulse oximeters, weight scales, ECG-capable smartwatches, and others), analyzes that data in real time, and presents findings to care teams through a web-based console dashboard that flags patients by risk level. The platform integrates with clinical EDC and EHR systems via CSISC and HL7/FHIR, and is designed for remote care, such as chronic disease management and remote patient monitoring at clinical scale. DrKumo was awarded as 1 of 4 vendors on the U.S. Department of Veterans Affairs Remote Patient Monitoring - Home Telehealth VA IDIQ contract. DrKumo also holds URAC Full Accreditation in Telehealth Support Services 2.0. DrKumo's prior engagement with FDA dates to 2019-2020, when the company (then IDLogiq Inc.) was selected by FDA under the Drug Supply Chain Security Act Pilot Program to develop a cryptographic medication authentication system. Two academic partners deepen that bench. Dr. Jack Bui at UC San Diego (Professor of Pathology, cancer immunology and tumor immune surveillance) brings the oncology depth that dose-escalation and first-in-human work will lean on. Dr. Jeffrey Glenn at Stanford (Professor of Medicine and of Microbiology and Immunology) is a therapeutics developer with several programs in clinical-phase development and sits on the FDA Antiviral Drugs Advisory Committee, so he brings both bench science and a working sense of how the agency weighs early evidence. The responses below address each question in Section II of the RFI. Each FDA question is reproduced verbatim, followed by DrKumo's response. This submission contains no confidential business information.