Extract to table

This memorandum is intended to serve as a comprehensive reference for the Solstice team, coordinating counsel, and regulatory consultants as the parties prepare for the initial IRB submission, and it identifies the critical-path activities that must be completed to support a target study commencement date of September 15, 2025

To achieve this milestone, IRB approval must be obtained no later than September 1, 2025, allowing a two-week buffer for the completion of site initiation visits at all six clinical sites

Calderwood & Harkness notes that each of the six clinical sites will need to enter into a reliance agreement or authorization agreement with Clearwater IRB, pursuant to which the site agrees to rely on Clearwater IRB's review and approval in lieu of review by the site's own local IRB (if any)

However, even IDE-exempt studies must comply with certain provisions of Part 812, including the requirements for informed consent (§ 812

The sponsor must document this determination in writing, along with the supporting rationale, and must submit the determination to the IRB as part of the initial review package

The IRB must make its own independent assessment of whether the investigation presents a significant risk or a non-significant risk