Clinical Data UpdateAn upcoming efficacy data update and anticipated alignment with the FDA on the registrational population could clarify the pivotal profile and support a BLA filing pathway.
Product Differentiation And AdoptionNon‑viral, off‑the‑shelf intravesical design with room‑temperature storage and simple handling may enable rapid uptake across community urology practices by fitting established workflows.
Regulatory And Manufacturing SupportSelection into FDA CMC development and readiness programs signals regulatory and manufacturing validation that can reduce launch execution risk and support supply readiness.