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In addition, there is a higher intensity of CD38 expression (measured by flow cytometry) in the more aggressive multi-hit variants, which allows further differentiation of the diseases and the use of CD38 as a biomarker for early diagnosis [14]

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Theyre wanting a certain amount of certitude that, frankly, is appropriate for most drugs, but not for this moment. Regulatory shortcuts exist that would allow the FDA to skip the more laborious approval process

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