Interesting article ... thanks @LearningEachDay
The U.S. Food and Drug Administration is moving to optimize the development of gene therapies, including encouraging the use of biomarkers to help get accelerated approval of therapies for serious conditions, an agency official said.
Hmmm .... Biomarkers you say Mr FDA ..... I wonder who has been focused on "biomarkers" in their BLA resubmission ? GLTAH
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