They key issue and it’s not going away anytime soon.
One party is being misleading in meetings between FDA and Mesoblast over the past 2.5 since the last CRL.
We need to determine who it is.
To be at this point again and the FDA saying an another trial again with more data. This could have been covered off by now.
Either Mesoblast have their head in the sand or FDA are providing incorrect direction at these meetings to say EAP long term data was suitable to cover data gap.
I am leaning FDA’s way as they said MSB you have complete data in your resubmission. But then basically say - we need more data from a trial in new CRL.
The problem is not going away - will the FDA ever be happy with the long term data? as to date it appears not and a new trial will just provide more of the same data.
Ann: Update on BLA for Graft Versus Host Disease, page-328
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