Hi all MSB shareholders,
Feels like the calm before the storm.
Storm = FDA approval of Rem-L for paediatric aGVHD
I am feeling confident because,
- MSB sole focus has been on delivering Manufacturing Quality Control Measures (@ world class Lonza facility in Singapore) that describe manufacturing assays confirming in-vitro and in-vivo cell potency for Rem-L for aGVHD.
- The above has occurred with FDA consultation because, the FDA have approved and Accepted Mesoblast's BLA Resubmission for Remestemcel-L for aGVHD else they would have not approved the resubmission or booked the Lonza inspection in Singapore.
- Once Rem-L is approved on Aug 2, 2023 (not long now) or before, this means in essence, that those manufacturing assays can be applied/accepted for all other MSB cell block buster products including aGVHD for adults, CLBP, CHF, Crohn's, All cause ARDS, Diabetes etc. and all other inflammatory disease treatments in our pipeline.
- The significance of FDA approval, is essentially that FDA are approving MSB allogenic stem cells as a product!!, so only the results of our magnificent trials for blockbuster CHF, CLBP, Crohn's, ARDS and many more to follow, matters when it comes to FDA approval
IMO, now just a waiting game as the the build up of FOMO kicks in and significant wealth increase for MSB shareholders over the short and long term.
IMO
GLTAH
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- Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-916
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