Ampio updated the regulatory status of Ampion. Statisticians representing Ampio and the FDA were to meet and discuss the clinical pathway of Ampion, the company’s lead drug, for the treatment of severe osteoarthritis of the knee, or OAK, followed by an additional, internal meeting that included reviewers from the FDA Office of Tissue and Advanced Therapies, or OTAT. That meeting has taken place and OTAT has provided final guidance that Ampio should complete an additional trial of KL4 osteoarthritis patients with concurrent controls that would be carried out under a special protocol assessment, or SPA, to obtain FDA concurrence on the trial design. A trial of approximately 150 KL4 patients, half in the treatment arm and half in the control arm has been designed, and Ampio will be filing the SPA submission in the near future. The trial is designed to expand by 150 patients if necessary.
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