RE:RE:RE:RE:RE:Type C Meeting TimingsThe FDA Type C meeting to discuss ONCY's novel biomarkers and surrogate endpoints for breat, pancreatic, anal, and colorectal cancers should open the door to ONCY's request for an Accelerated Approval for pancreatic cancer as a disease with an orphan and rare disease with an unmet treatment need.
The reason for this is that ONCY had run several Phase 2 clinical trials for this cancer and meets the FDA's trial requirements, particularly now that PanCan is funding another Phase 2 with Folfirinox, which currently has FDA approval followed by tZthe February 2024 approval of another Folfirinox derivative Nalirifox.
https://pancan.org/news/fda-approves-new-first-line-treatment-option-for-metastatic-pancreatic-cancer-what-you-need-to-know/