Scholar Rock said an EU opinion for its experimental SMA treatment may be delayed to later this year as regulators await the U.S. FDA’s classification of a manufacturing facility referenced in the company’s European filing. The regulatory timing uncertainty is a near-term headwind, though it is not described as a safety or efficacy issue.
Scholar Rock said an EU opinion for its experimental SMA treatment may be delayed to later this year as regulators await the U.S. FDA’s classification of a manufacturing facility referenced in the company’s European filing. The regulatory timing uncertainty is a near-term headwind, though it is not described as a safety or efficacy issue.
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mildly negative
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