Ampio Pharmaceuticals announced that on March 11, 2019, the company resubmitted a Special Protocol Assessment with the FDA for a confirmatory Phase III clinical trial of its biological drug, Ampion, for the treatment of patients afflicted with Osteoarthritis of the Knee, or OAK. Michael Macaluso, Ampio’s CEO, said: “After a series of interactions with the FDA, we believe we have addressed and answered all questions regarding trial design. The FDA confirmed they would respond to our SPA submission no later than April 25, 2019. The FDA guidance regarding our trial design was in agreement with the advice we received from multiple independent statisticians who analyzed our clinical results of nearly 1,000 KL4 patients. These patients, taken as a group, provided statistically significant results compared to patients receiving the saline control.”
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