Extract to table

The IDE supplement filing target of March 15, 2026 is only 13 days after the target CTA execution date, and TMRI's regulatory counsel has advised that the executed CTA (or, at minimum, a substantially final draft) must be referenced in the IDE supplement submission

150 requires the sponsor to submit various reports to the FDA, including IDE supplements, progress reports, and final reports, all of which must be supported by the underlying Trial Data

Part 11, which governs electronic records and electronic signatures, the sponsor must maintain adequate controls over electronic data systems to ensure data integrity, audit trails, and the ability to reproduce data for regulatory inspection

G260012), must retain control over Trial Data to fulfill these regulatory obligations

The IDE supplement referencing the cadence-3 Protocol and the CTA must be filed with the FDA by March 15, 2026

TMRI must be able to represent to the FDA that it has unrestricted authority over the data that will be generated in the trial