"The BLA resubmission of January 2023 included long-term...

"The BLA resubmission of January 2023 included long-term follow-up data from the Phase 3 trial by the Center for International Blood and Marrow Transplant Research (CIBMTR) showing 50% survival through more than 4 years of follow-up for remestemcel-L treated patients in the Phase 3 trial for whom less than 20% survival at two years was expected based on disease severity. The resubmission also included a post-hoc propensity matched study showing 6 month survival was 67% with remestemcel-L vs 10% with other unapproved therapies in highest-risk patients as identified using the Mount Sinai Acute GVHD International Consortium (MAGIC). These pediatric data provide further support for use of remestemcelL in the proposed study in high-risk adults with SR-aGVHD"

But I want an adult RCT screamed the stubborn King as he stamped his feet....

That is an appalling decision for patients. I've taken a decent hit to my portfolio on this. Nothing compared to others on here. Its hurting, but that's investing. The real travesty are the patients in this. Those are compelling results and patients are going to die, who might otherwise not.