RE: Poster Boys (and Girls)8 Apr 2024 07:51
Yes I saw that. I also note 'This approval was granted under the FDA's Real-Time Oncology Review programme after securing Priority Review and Breakthrough Therapy Designation for Enhertu in the US in this setting. The US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, Enhertu is also under regulatory review for the same indication by regulatory authorities in Australia, Brazil and Singapore.' Somewhat different approach than AGL's.