Isofol Medical applied for a special protocol assessment (SPA) earlier in March this year and the application is currently under review by the FDA. After feedback from the FDA, the company has now reached consensus with the agency concerning key parameters of the study design of the upcoming pivotal trial in colorectal cancer. Additions to the application were requested, however, resulting in a delay of the initiation of the trial. Despite this, we see positive glimpses in the feedback from the FDA, giving the project a clearer path forward.