Next ... fast track & breakthrough designation
Just want to translate this for the market as it means fast track designation
Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program's registrational study. Including a PFS endpoint could substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep's path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients."
If the data evolves from SD to PR it could move to CR (complete responses, i.e. cure for cancer) then we might get breakthrough designation.
Fast tracking will shave 2-3 years, so we could be fully valued within 18-24 months of designation.