Wrong....Look at what happened when they submitted the CRL."•...

Wrong....


Look at what happened when they submitted the CRL.
"
• new data showing that the validated potency assay has low variability and can adequately demonstrate manufacturing consistency and reproducibility,
• establishment of a new specification for release of commercial product based on extensive clinical data which provides assurance that future batches ......
"

So MSB has refined the potency release criterea after the trial, which would then mean product that missed this testing on shelves would need to be all re-tested. Maybe MSB only did partial or donor specific or partial lot testing and that is why MSB is saying they have some of the data the FDA need, but need some more work to get the rest of hte data.

My hunch , based on what MSB appears to have done is exactly what SI and Krause both said. The FDA want to be convinced product on the shelf is substantially the same as product used in the trial.... what they left out was..... After we changed the release specification.


The FDA request could have another meaning though also, which is we don't care if you changed the specification, we want the original asssay you used to be used again, and then post approval MSB can update the release spec.


Again if FDA needed Mesoblast to do another trial, they would have said as much plain and directly. You must do another trial.

Since they have not, they clearly are aware of what MSB could provide without another trial could be enough for approval and that is what they asked for. Failing that - another trial.


Big scheme of things it means the children won't be treated until the adults are approved.

Delay is now on the FDA's hands. Given no safety or efficacy concerns, and no approved treatment...... mmmmm FDA running out of excuses.