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[2] However, pursuant to FDA Guidance Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Jan 2018), 503(a) and 503(b) facilities may still mix, dilute or repackage

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Blots were further incubated with anti-rabbit horseradish peroxidase (HRP)-conjugated secondary antibody (1:5000, 31460, Thermo Scientific) for 2 h at room temperature, and immunoreactive bands were detected using the enhanced chemiluminescence (ECL) method in a ChemiDoc XRS System (BioRad) with Image Lab software

Clinical experience strongly supports its use for the indications below but we're working with promising preclinical data, not robust human RCTs