Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-955

You don't think FDA said "we can refile"

Not in the three words you are using, nor in the words Silviu has attributed to him by the reporter no, I don't think the FDA would speak like that.

Yes MSB like any applicant is allowed to file a resubmission (and potentially get its filing back in 14 days if its deemed incomplete or not addressing the CRL) or, alternatively, have it taken further in for a proper review when its would get a PDUFA date.

Yes there was a pause then an announcement on the 27th of March. Consistent with them getting some feedback.

"U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD)."

Yes MSB said that. "appears sufficient"

They (MSB) also said

"Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterisation issues".

Potency assays are a form of product characterisation.

Nowhere in that announcement do they say anything about potency assays - and in the 7th of March 2024 - potency assays was what they were going to the FDA about.

"remaining product charactisation issues" 27 March 2024 - Mesoblast. After the trading pause - in the official announcement.