Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1009

Two points.

1)The longevity data from MSB-GVHD001 could have been obtained fromMSCs that were potent for reasons other than the two part matrix (its the IL2Ralpha part much more than the TNFR1 part that I havereservations about. As did the stats expert at ODAC - Susan Halabi orHalini or whatever).

Anyone looking atthe figure bazsa has now decided to repost can see every one of the11 dots has a different x-value (if x is the horizontal axis) (where x is %IL2Ralpa inhibition invitro). No vertical line cuts two points. Any two patients gettingtreated from the same batch that could be graphed (because theyweren’t confounded say because they got multiple batches of cells)should produce two dots with the same x-value one exactly above theother as they both got the same batch of % IL2Ralpha inhibiting cells– but had different reading on their blood (where the blood readingare percentage change for T cell activation after 28 days versus attreatment time).

2)If MSB had supplemented the data with later fresh EAP data or COVIDdata (which could hardly associate with the GVHD longevity) why wouldyou imagine they'd keep that to themselves rather than just saythat's what they did and that the FDA has responded positively tothat ?