[ATTACH] "FDA indicated its willingness" ..... sadly that...

"FDA indicated its willingness" ..... sadly that doesn't mean they will agree .... imagine if the 'minutes' state the opposite and yes @Stonks100 we are still going on about potency assays years later ? How this cannot have been agreed upon in the 3 years after the first CRL (next week) and all the supposed 'collegial FDA discussions' during that time is beyond me ? either the FDA keep changing their minds or multiple Mesoblast personnel are not hearing what they are asking for ?


I do however read a glimmer of hope in the announcement that if the 'new potency assay' data is what Mesoblast believe it will be and it matches product used in the pediatric Phase 3 trial MSB-GVHD001 there is a chance the FDA may consider the pediatric approval in the coming months but remember nothing moves quickly at the FDA and it is only a slim chance IMO


Time to get on with the FDA CHF meeting I say .... it was claimed that the potency assays were agreed upon by the FDA for this indication years ago and CHF (Rex-L) was a phase 3 RCT conducted over 5 years after all so surely we have a strong case for an AA based on the results ?