Prior to the resubmission, the FDA guided Mesoblast to resolve...

Prior to the resubmission, the FDA guided Mesoblast to resolve outstanding chemistry, manufacturing and control (CMC) issues before initiating any additional clinical trial.Despite knocking back the resubmission, the FDA did acknowledge in its review the company had made some improvements to assay performance compared to previous versions used in its pediatric phase three trial.
The above is from market Herald.
It doesn't read to me the manufacturing issues have been resolved and has FDA completely satisfied.

I followed MSB since 2016, in and out, made profit and loss , overall lucky enough to be Breakeven.
I used to think Hope is enough for me to stay invested in this company. But for 8 years, only two FDA applications submitted and both rejected
A lot of guess work here,some pointed out that potency and batch consistency were not addressed by the FDA this round, they must be okay with it. Well, they just need to find out fault in you and knock you back.
MSB went for a short cut since last rejection, thinking the paediatric GVHD is a easy bet to get FDA approval. It's like asking for a specialised driver' s licence before even getting a basic drivers licence. Paediatrics are a specialised sub categories of human medicine. So FDA asked for adult data.
Follow the study design, meet the requirements, no shortcuts.
Sad to see SP Back to 20 years ago.