The trial’s protocol remains under development, and the study would require a validated biomarker assay for measuring serum VEGF-A levels, which also is under development.
Finally, based upon recently conducted studies, submission of the results would not be expected until at least 3 years after enrollment begins, she said.
Genentech is expected to defend its study proposal and offer more details about it during the hearing’s second day.
This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.