2023 The Final Countdown, page-2232

I don't want to let myself down.

Just read one of my posts the day before the last CRL on Oct 1st 2020, where I said even a CRL might be a good thing, because it could set us on a pathway to approval. I truly believed that then and now.

2 years later and we have an independent study on the link between our IL2Ralpha potency assay and survival.

10 day manufacturing inspection lead to no violations found.

We have another indepent study by the CIBMTR registory comparing survival with propensity matched paediatric patients in their database, with the long term survival follow up from our trial.

We have Mesoblasts' own comparison of the most recent, as well as the largest ever Paediatric study, and the only study that lead to approval, survival rates of control and treatment all compared with MSB coming out on top in this real world evidence by a country mile.

We have the ODAC 9 to 1 vote which occurred before all of the new data was available. Could you image what would have been said if ODAC saw a 50% survival at 4 years.... !!

Could you imagine what ODAC would have said at 90 to 100% survival in the highest risk groups at 180 days, recieving the most potent product......!!!!

FDA wanted to set a high bar, and IMO a high bar has been achieved by MSB. Correlating potency with increased survival over all other therapy types, including the only other approved therapy.

Safe.... The safest treatment option out there
Efficacy.... 2 year Mortality data speaks for itself
Repeatable...... IL2Ralpha assay and P values speak for themselves

It's been a long time coming for some holders, me and Dr Krause ( Ex FDA deputy chief for vaccines ) can feel it.

NEXUS Point Approaching !!!!!!

Sure the data could be better.... instead of 90-100% survival in the highest mortaliry risk group that recieve the most potent cells.... could be 100 % cure, and I'm sure Si and the team are working towards this goal.

Worst case we get a new CRL, for new reasons that are unknown at this stage, CLBP trial kicks off, and we expect good results, supporting approval in the biggest application MSB has by around 2025/26.

CLBP phase 2 results...




CLBP phase 3 repeated results


A VAS score change of 30 points is roughly the equivalent of a 50% pain reduction.....An average of 50% pain reduction !!!!!!!

All they need to do, is repeat the results a third time, and get approval !

That will be the equivalent of Musk launching the first starship to Mars.