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

The BLA resubmission to the FDA for the treatment of children withSR-aGVHD has been submitted to the FDA.

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 (chemistry, manufacturing, and controls) 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 however have asked for more information as part of the CRL. Total QuarterlyRevenue for our working cells that saved countless lives in Japan, JCR Pharmaceuticals revenue for the QuarterApril 1 to June 30 2022 was

·1,041 million yen

·~ $US 7,878 million

·~ $AU 11,353 million

So yearly Revenue in Japan is $US 7.878m x 4 = $US 31.5m

Of course we all know the US market is a minimum of 4x Japanese market.

So given MSB will self market,

MSB Revenue for aGVHD in USA will potentially be

4 x $US 31.5m = US$ 126 million p.a. REVENUE given we have our own salesteam and selling directly.

JCR Pharmaceuticals in Japan is alreadydemonstrating our manufacturing processes are extraordinarily repeatable andconsistent in batch potency and effectiveness, ourcells work and our manufacturing process is consistent - that is withoutdispute 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 the approval by the FDA for Remestemcel-L for children with aGVHD soon.

As previously stated by other shareholders, this will mean the "FloodGates have opened" !!

Yes, it will, because once Remestemcel-L aGVHD is approved then the others will follow in quick succession along wit label extensions... IMO.

Add your massive global Revenue numbers below...because this is no joke, only the beginning of the first $1 Trillion market Cap company on ASX IMO.

CHF
CLBP
All inclusive ARDS
Crohn's disease

DYOR
GLTAH