Ampio (AMPE) Completes Pre-IND Meeting with FDA's CBER for Ampion
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Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), has completed a pre-IND meeting with the Center for Biological Evaluation and Research (CBER) division of the FDA that took place on May 10th regarding Ampio's lead biologic, Ampion for the chronic treatment (repeat injections) of pain in osteoarthritis (OA) of the knee.
The purpose of the meeting with CBER was to obtain guidance for the clinical path to a Biologics License Application (BLA) for Ampion™ for OA of the knee in the US and clarity as to the steps necessary for Investigational New Drug (IND) submission. The discussions included manufacturing criteria and the scope and design of the phase III trial(s).
The purpose of the meeting with CBER was to obtain guidance for the clinical path to a Biologics License Application (BLA) for Ampion™ for OA of the knee in the US and clarity as to the steps necessary for Investigational New Drug (IND) submission. The discussions included manufacturing criteria and the scope and design of the phase III trial(s).
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