Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1026

Laughable that you now try to subtly sow doubt in the EAP data as well ... you know the data from hundreds of patients you question in your comment in brackets ( ) in the above post as you weave it into the same conversation around COVID-19 ARDS data ?


https://clinicaltrials.gov/study/NCT00759018?intr=remestemcel-l&rank=6

_{Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD}



The fact remains, Mesoblast has an enormous amount of data in relation to Remestemcel-L and treating patients with sr-GVHD .... some might even say an abundance of data in comparison to it's competitors like (say) CYP who have treated just a handful of patients (drop in the ocean type scenario) but do keep drawing false conclusions from the limited amount of publicly available data if it helps you try and justify your continual questioning of what Mesoblast has stated through official ASX announcements ?


In a nutshell, the FDA has said they are happy for Mesoblast to refile the BLA so they have probably seen a lot more data than the likes of an anonymous poster on HC - just sayin'






GLTAH