InVivo Therapeutics Holdings Corp. (NVIV) announced today that it has received conditional approval from the Food and Drug Administration for proposed changes to the protocol and supporting documents for the safety trial of its first investigational product, a degradable polymer scaffold for spinal cord injury. InVivo submitted these proposed changes to the FDA on November 21, 2013 and will follow the FDA's approval conditions in their entirety in a submission to the FDA next week.
InVivo also plans to send its revised protocol and other supporting materials to six sites next week so that those sites can start their Institutional Review Board reviews and finalize contracts with InVivo. Based on the specific experience of these sites, InVivo expects that these Institutional Review Board reviews and contract finalizations will take approximately 4-12 weeks, and that the first site will be ready to accrue subjects in the first half of March.
InVivo Interim CEO Michael Astrue said, "Today's news is one more critical step forward toward testing our scaffold on our first patient."
InVivo Therapeutics Holdings Corp.