Breaking News, Trials & Filings

Ampio Gets Pivotal OAK Confirmation

FDA accepts study as pivotal for osteoarthritis BLA

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ampio Pharmaceuticals has received correspondence from the FDA confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion for the treatment of osteoarthritis of the knee (OAK). The FDA’s letter summarized the FDA’s conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting. According to the company, the letter noted that study AP-003-A ca...

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