Ortho Regenerative Technologies reported a successful pre-investigational drug meeting with the FDA in February and is now preparing for its rotator cuff phase I/II clinical trial.
Four things to know:
1. Ortho RTi began a 6-month preclinical study in January to provide data and address FDA requirements to finalize the phase I/II procedures.
2. The in-life portion of the study and its data is completed.
3. Final reporting and IND requirements related to manufacturing and stability are expected in the fall.
4. The IND filing is expected by the end of the fiscal year.