Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-69

Big breath and time to revisit the statement:

The resubmission contains the following new information:
• new long-term survival data through at least four years for children enrolled in the Phase 3 trial,
• new outcome data following remestemcel-L use in high-risk disease activity and on survival using
propensity-matching of children in the Phase 3 trial and controls stratified by validated biomarkers,
• new analyses of prospectively obtained data relating the validated potency assay, which was used
to release product for the Phase 3 clinical trial and reflects the primary mechanism of action, to in
vivo bioactivity and overall survival,
• new analyses of clinical data obtained prospectively relating manufacturing changes implemented
during product development, prior to Phase 3, to progressive increases in potency and to improved
survival outcomes of children with SR-aGVHD treated with remestemcel-L under expanded access,
• new data showing that the validated potency assay has low variability and can adequately
demonstrate manufacturing consistency and reproducibility, and
• establishment of a new specification for release of commercial product based on extensive clinical
data to provide assurance that future batches of remestemcel-L will have attributes supportive of
expected survival outcomes.

Lots of new data and further elaboration and analysis of existing data to address the FDA's concerns, done after two years of constant consultation with OTAT and CBER.

You wouldn't bet against them would you? I think you will see some steady unravelling of shorts and growing long investor interest with much improved odds at the first ever FDA approved allogeneic Mesenchymal stem cell therapy.....