The FDA has requested additional Chemistry, Manufacturing, and Control ("CMC") related information. The Company is confident in its ability to address and provide the FDA with the required information and testing data over the coming four to six weeks.
Ortho-R is designated as a Drug/Biologic combination product, by the FDA Office for Combination Products. The jurisdictional assignment for Ortho-R will be the Center for Biologics Evaluation and Research (CBER). The news was announced today by Ortho...
As a result, the Company is in the position to submit its Investigational New Drug while completing its pivotal study and confirms the timeline to initiate human clinical program by year end.
2/4/19: Both key scientific studies validate its product's ability to improve the repair of two distinct joint tissues, the rotator cuff tendon and articular cartilage.
4/2/18: Conducted by researchers from Montreal's prestigious École Polytechnique, the pilot dose escalation study used MR imaging outcomes, read by two blinded experts at 3 intervals, to compare the results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.