Precisely,The BLA resubmission to the FDA for the treatment of...

Precisely,

The BLA resubmission to the FDA for the treatment of children with SR-aGVHD will be soon IMO.

I believe that the FDA are seeking to approve their first stem cell medicine, however, they are being cautious and seeking more clarity on CMC for manufacturing. The FDA are well aware of the safety, efficacy and manufacturing quality of our cells based on years of use in Japan for both children and adults treating aGVHD.

JCR Pharmaceuticals revenue from April 1 to Dec 31 2021 was 2,648 million yen ~ $US20,362,000

Total royalty to MSB using our working cells that saved countless lives in Japan against aGVHD for period April 1 to Dec 31 2021 = $US7,490,000

https://hotcopper.com.au/posts/61137366/single

JCR Pharmaceuticals in Japan is already demonstrating MSB manufacturing processes are extraordinarily repeatable and consistent in batch potency and effectiveness, our cells work and our manufacturing process is consistent - that is without dispute given multi-year success in Japan for successful treatment of aGVHD - Fact

I believe that the FDA want to approve Remestemcel-L for children with aGVHD given the significant unmet medical need and they have been working with MSB to do just that.

I look forward to MSB confirming resubmission and then approval by the FDA for Remestemcel-L for children with aGVHD soon.

DYOR
GLTAH