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A randomised controlled trial is considered the gold standard of clinical evidence
On July 18, 2025, FDA followed through by issuing Genentech a complete response letter for glofitamab (Columvi) plus chemotherapy in diffuse large B-cell lymphoma, directly citing the Starglo population-representativeness concerns raised by the advisory committee ( [110] )
The 23% substitution rate and extreme quantity accuracy variations documented in independent testing are disproportionately concentrated in this category
While pre-clinical data has been encouraging, clinical evidence remains limited
They found "no studies that administered BPC-157 to humans via the proposed oral, SC, nasal, or transdermal ROA" [12]
This wasnt an isolated study
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