Hi GinoE,
i was also intreguid about this and sent a follow up email to IMU. Questions and responses are below -
1.Orphan Drug Designation forAzer-Cel– In theAGM presentation, both Orphan Drug Designation and Fast Track Designation werementioned. However, in the latest slide, Orphan Drug Designation has beenremoved. Could you provide insight into why this change was made? Has theapplication been withdrawn, or was it not granted by the FDA?
The team is considering whether or not to apply for an orphanstatus for the number of incidences of Diffused Large B Cell Lymphoma (DLBCL),after the Fast Track Designation.
2.Phase 2 Start-Up for VAXINIA– The AGM presentation in January indicatedthat Phase 2 start-up was expected, but in the latest slide it has beenremoved. Could you confirm whether Phase 2 has been delayed or cancelled and,if so, what factors contributed to this decision?
For CF33, we are weighing our options for which indication andstudy we would like to discuss with the FDA for a Phase 2 study.
(20min delay)