That chart you go on about is in effect part of the validation of the potency assay that was in place for that trial, there is a lot of data MSB had before hand that support the hypothetical ( at time of 001) potency assay . We also have new data.
It is interesting that the data has not changed. This indicates that we are looking at data from the old potency assay as it is my understanding that we have reverted back too the old assay. Wasn't this chart in the ODAC presentation? Yet FDA found inconsistentlices in the new potency assay that led to the first CRL. Good because this is proof that 001 was standardised at the time of the trial.
( the reason given for CRL 2 )
JB
"do you think Mesoblast have shown that the good results obtained from just three donors in the Study 001 (I'm assuming you know that) can be reliably attributed to the specific potency assay components that MSB used (specifically level of TNFR1 s and inhibition of IL2Ralpha on co-cultured T cells) OR do you think that because those three donor were essentially young healthy donors they might have had potent cells for other reasons?"
Yes I do, this study 001 validates the potency assay, remembering that the potency assay was in place already.
There will always be other cell attributes that could be critical to the patient outcome, do you think MSB would have overlooked this? Many of these attributes would be tested for and parameters set based on past performance setting a standardised product. They are what would be called quality attribute tests not potency assays as they have not been linked to patient outcomes.
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