Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-476

"we've provided all the data to the FDA and we think more than meets their, um, their criteria."


I think ppl are struggling to put together the sequence of events and outcomes.

This interview was done obviously before FDA gave their recent feedback resulting in the rushed announcement last week, without waiting for the minutes of the meeting. So the new assay data SI refers was already provided to the FDA. Their decision to accept the GVHD-001 is likely a result of this new data.

Now why would this new assay information, probably highly IP sensitive, be available in the public domain?

I think as Stockrock has pointed out, the announcement being put out prior to FDA minutes being provided in 30 days, the usual mesoblast practice, is to ensure a fully informed market to highly price sensitive news. Was it price sensitive or a bit of puff? Maybe ask SP to see if has an opinion on the matter.