AdAlta CEO and Managing Director, Dr Tim Oldham said: “The FDA agreeing to meet us is the headline. What matters more is what it took to reach the point where we could request the meeting. Our team has worked through hundreds of documents from SHcell covering how EW-001 is made, how it is tested and how it has performed in patients in China. We have worked with some of Australia’s most experienced CAR-T and mesothelioma clinicians to turn that into a draft Phase 1 clinical trial protocol. And we have worked alongside Cell Therapies to finalise manufacturing technology transfer and optimisation plans. A pre-IND briefing document is only possible once all of those pieces exist and fit together, so this is a milestone for the whole program and for our partners, not just for our regulatory team. Now, consistent with our capital efficient approach, we get to test our thinking with the world’s most experienced regulator of cell therapies before we commit to the costliest parts of the program.”