“We are working with the FDA towards a PDUFA date for our CARTITUDE-4 indication in April 5, and with EMEA towards an anticipated CHMP opinion in the first quarter of 2024.”

In context

“d and at the same on the potential of CARVYKTI to be $5 billion plus asset at peak year sales. Regarding the ODAC that you commented, we are very confident on the data of our Phase 3 CARTITUDE-4 study that as a reminder, support the efficacy and safety of CARVYKTI in one to three prior lines in treatment of patients with relapsed/refractory multiple myeloma. We presented the results at ASCO, as you know. And we also published those results in the New England Journal of Medicine. And we very much look forward to review the updated survival and safety data with the FDA ODAC in the future. We are committed to work with the FDA in the continued development of CARVYKTI. And we continue to have the focus on bringing this in immunotherapy to multiple myeloma patients in earlier lines of therapy. We are working with the FDA towards a PDUFA date for our CARTITUDE-4 indication in April 5, and with EMEA towards an anticipated CHMP opinion in the first quarter of 2024. So overall, we feel confident about the risk benefit profile in this indication and about the future of CARVYKTI. Regarding your manufacturing question, we've done a significant progress in our manufacturing capacity, which is a major driver in the continuous growth of CARVYKTI. On the cell processing side, we have doubled our cell processing capacity in our Raritan facility. Since 2023. We are making progress to your point, Terence, in our European cell processing facilities. We are already manufacturing the first batches of CARVYKTI for clinical use this month of January. And we also have contracted additional capacity, external capacity to scale up production and increase our ability moving forward that will start mid this year. On the other hand, we have also made significant progress”