Ann: Submits New Information to FDA IND File for SR-aGVHD, page-298

I do worry that the FDA will throw a wrench in the works of the previous potency assays for which Rex-L already got the tick in respect of CHF, particularly given the significant new work that MSB has done in respect of the updated assays for Rem-L.

Can just see them expecting MSB to go back to the drawing board and make sure that they put Rex-L through a similar exercise as has now been done for Rem-L (particularly if that new "reasonable" assay is approved for GVHD). It seems logical for the FDA to do so, of course, and we really don't really know how the previously "approved" potency assays for Rex-L would look when viewed through the lens of the new Rem-L assays. They might no longer be fit for purpose in the FDA's eyes, comparatively speaking.

That said, I fully assume that MSB has Rex-L team members working on updating all of its info for that product, including the assays, particularly with the CHF meetings with the FDA in play.