Ampio Pharmaceuticals has received comments from the U.S. Food and Drug Administration (FDA) regarding their Special Protocol Assessment (SPA). The FDA recommended the Company not start their confirmatory trial without obtaining FDA concurrence on the trial design. The Company agreed with the comments they received from the FDA and immediately sent a revised SPA to the FDA for review.
"While we will not officially start the trial until the SPA is approved," said CEO Michael Macaluso. "Extensive preparatory work is already underway. We hope to start the trial in May."
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
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