Stock Watch: Full Approval And Surrogates Await Clinical Validation
Time Is A Great Leveller Among Outcome Measures
When surrogate endpoints are used for accelerated approvals in advance of more compelling functional outcomes, how long should the duration of the confirmatory studies be?
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Regulatory Flexibility: US FDA Approves Amylyx’s Relyvrio For ALS Despite ‘Degree Of Residual Uncertainty’
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