NVIV - InVivo Therapeutics soars 15% on FDA acceptance of preclinical module for HDE submission

The FDA has accepted InVivo Therapeutics' ([[NVIV]] +15.2%) preclinical module, one of three individual modules required for the company’s humanitarian device exemption ((HDE)) application.FDA acceptance indicates that the Agency has completed its review and has no outstanding questions.Review of the remaining two HDE modules, when complete, will be required prior to a final approval.The HDE submission will not be complete until the manufacturing and clinical modules are also submitted. InVivo is actively enrolling patients with acute spinal cord injury into its 20-patient INSPIRE 2.0 study, a pivotal trial of the Neuro-Spinal Scaffold.

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InVivo Therapeutics soars 15% on FDA acceptance of preclinical module for HDE submission