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The 180-day exclusivity can be forfeited if the first filer fails to market commercially within a specified window after the FDA makes its application tentatively approvable, fails to comply with FDA requests, or is found to have engaged in patent settlement conduct that triggers forfeiture provisions under the MMA (2003)

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Blindly pursuing the intervertebral disc repair strategy to promote cell proliferation and anabolic activity without considering the nutritional environment in the degenerate disc may not be the correct direction of intervertebral disc regeneration