BassieNL schreef op 17 oktober 2019 20:08:
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Nee, de standaarden van de EMA zijn niet veranderd.
De ´standard of care´ is veranderd:
Feedback from the EMA now indicates that the phase 2 data and historical T-cell deplete control data do not provide adequate support for a marketing authorization due to the evolution of the standard of care with the post-transplant cyclophosphamide (PTCy, aka Baltimore) protocol.” Wordt er in fase 3 wel met de juiste ´standard of care´ vergeleken ??