RE:Adlai Nortye Phase 2 Pela/Pax study could lead to US BLAWhat this all means is that Adlai Nortye's Phase 2/3 'bridging' Pelareorep-Paclitaxel study in metastatic breast cancer could directly lead to the simultaneous regulatory BLA filing with the FDA and China's NMPA for the marketing approval of Pelareorep and this filing could occur in advance of the conclusion of this Adlai Nortye study since the FDA accepts a rolling submission as the data comes in.
A rolling FDA BLA regulatory submission would be supported by the Adlai Nortye Phase 2/3 'bridging' study and ONCY's IND 213 study data.