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Posted On: 05/30/2018 3:03:17 PM
Post# of 30015
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Dr. Michael T. Ropacki, newly-appointed Chief Medical Advisor for the Alzheimer's Blood Diagnostic LymPro Test program. "The Food and Drug Administration's recently released draft guidance on Early Alzheimer's disease drug development reflects their current thinking on patient and clinical endpoint selection, as well as patient staging. This draft guidance emphasized the role that biomarkers play in the reliable identification and potential stratification of patients, as well as how biomarker changes may, in principle, serve as the basis for accelerated approval. This provides a unique opportunity, as LymPro has the potential to help fulfill the need for a reliable and cost-effective blood-based biomarker for patient identification and may also provide needed evidence on biomarker change over time."
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