Australian newspaper article, page-120

U.S. FDA has informed the company that following additional consideration the
available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of
the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients
with steroid-refractory acute graft versus host disease (SR-aGVHD).

The above meant the reason for the CRL had been resolved

CEO is now quoted in the Australian as saying the new data is good enough for approval in kids, the official line was
“We thank the agency for their collaborative approach. The responses and guidance from FDA are clear
and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SRaGVHD,” said Mesoblast CEO Dr. Silviu Itescu.
Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining
product characterization issues.

The new data needs to be put in the BLA resubmission without ERROR and allow the licensing process to conclude.


Why he said it now? That's interesting but irrelevant to the message itself- approval forthcoming.


No spare cash left now


GLTALTH's

Reg- all my opinion only- read your own tea leaves