Isofol reports FDAs feedback from the ongoing special protocol assessment (SPA) process
In March 2018, Isofol Medical AB (publ) submitted a Special Protocol Assessment (SPA) to the United States Food and Drug Administration (FDA). The SPA process aims to confirm the specific targets to be met in the ISO-CC-007 study, the pivotal study with arfolitixorin in first line metastatic colorectal cancer (mCRC). In the feedback received from the FDA the company has reached a consensus with the FDA on the most important parameters for an SPA agreement and will now complete the SPA submission with the outstanding issues commented on by the FDA.The FDA agreed: · that the primary