RE:RE:RE:RE:RE:Clinical Trial Size in Orphan and Rare Diseases No one said or implied that Breakthrough status is the same as Fastrack status. In spite of this Fastrack offers the same benefit of FDA access as Breakthrough particularly since ONCY has been reporting on surrogate endpoints, which like Breakthrough, opens the pathway to Accelerated Approval, which is recommended given ONCY's positive Phase 1/2 data in their GOBLET-1 adaptive clinical study in metastatic pancreatic and anal cancers.
And ... Accelerated Approval in the context of an adaptive clinical trial involves a transition from a Phase 2 trial to a Phase 3 confirmatory trial ( traditionally known as a Phase 4 post-marketing study).
Furthermore ONCY has been developing and presenting biomarker data along with its positive clinical data, which demonstrates pelareorep's ability to remodel the TME thus synergistically benefitting the addition of a checkpoint inhibitor such as atezolizumab in both orphan cancers and rare diseases.
Once again Quentin30, the little knowledge you have in this space is a dangerous thing, given your history of "indiscriminately throwing mud at the wall ... and seeing what sticks". I have already accused you of being a perpetual prevaricator, and this time is no different.