Oncolytics Biotech Inc ONCY

Next ... fast track & breakthrough designation

[SundayMovies]

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.

[Noteable]

ONCY's fast-track status will quickly turn into ONCY's aquirer's Accelerated Approval filing. This gives ONCY's acquirer a lot to talk about when the time arrives.

[inthno]

So we must understand that the company already has fast track designation for this indication as they do with the panc. Also of note is they are talking about 2 primary endpoints for the trial and not just one so that if pfs for example does not meet the trial endpoint then they move on to the os part of the trial so it COULD reduce the timeframe for meeting the trial endpoints but might not. The