The BLA resubmission to the FDA for the treatment of children...

The BLA resubmission to the FDA for the treatment of children with SR-aGVHD has been accepted by the FDA with PDUFA date of Aug 2, 2023

• Mesoblast has generated substantial new data, as previously discussed, that it believes establish the relevance of the proposed potency assay measuring remestemcel-L’s in vitro anti-inflammatory and immunomodulatory activity to the in vivo clinical effect of the product in the Phase 3 trial in children with SR-aGVHD, including long term survival and biomarkers of in vivo activity

• Mesoblast has provided these new data to FDA and address all chemistry, manufacturing and controls (CMC) outstanding items as part of the BLA resubmission. The resubmission was accepted, and is de-risked 100%, because the FDA sent 4 inspectors for 10 days to Singapore to observe the manufacturing process and CMC's with no FORM 483 issued meaning the Inspection has passed.

I believe that the FDA are seeking to approve their first off the shelf stem cell medicine, however, they were just being cautious and seeking more clarity on CMC processes 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.

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 revenue for 9 months from April 1 to Dec 31 2021 was 2,648 million yen ~ US$20,362,000 annualised to ~US$27,150,000

USA market is about 4 times Japan however USA pricing will be much higher.

JCR Pharmaceuticals in Japan is already demonstrating our 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 will 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 approval by the FDA for Remestemcel-L for children with aGVHD well prior to August 2, 2023.

DYOR
GLTAH