Abeona Therapeutics (ABEO -2.2%) reports that it expects to initiate a Phase 3 clinical trial, VITAL, evaluating autologous collagen 7 gene-corrected cell therapy EB-101 in patients with recessive dystrophic epidermolysis bullosa in Q4.
It recently met with the FDA and, based on its feedback, is clarifying certain aspects of the study, including CMC information related to product transport and the protocol to assess comparability of certain clinical materials used in the trial.
Shares sold off in November 2018 after it announced a delay in the start of the study to allow time to address the above issues.
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