seems when things happen they happen quickly:
1. Biomarker to detect MRD approved 30
September 2018.
2. FDA draft guidance for use of MRD biomarker as end point and surrogate endpoint 31 January 2019.
3. Final FDA guidance for MRD 31 January 2020.
What instigated this is the method to ‘detect’ MRD. If we contrast EMD and the MD Anderson trial this is specifically what they are aiming to achieve. Interesting how much weight the FDA add by endorsing the biomarker.
Might do some more digging and educate myself before jumping to conclusions.
Ann: Updated Strategy and Investor Presentation, page-386
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