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The applicant finally asserted that the study data showed improvement in investigator-rated ulnar neuropathy assessed by the Modified McGowan Classification of Ulnar Nerve Neuropathy and that there have been no second revision procedures performed, no reports of recurrences of ulnar neuropathy, and no safety issues

What stands out is not just that these studies met their endpoints, but that many of them changed the question being asked from does it work? to how fast should this become standard? This level of impact signals a healthier, more productive late-stage pipeline and a clearer connection between innovation and patient benefit

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