2024 Here we go again., page-5

INCY has a possible chronic GvHD treatment which is a different disease to aGvHD, even though Meso will probably try to expand the label into cGvHD after they've been approved for aGvHD. Meso isn't likely to be active in cGvHD for at least a couple of years and they would have to show efficacy above Incy's treatment if INCY is approved (which isn't guaranteed).In the meantime, back pain and heart are potential blockbusters and far more important to Meso's prospects than cGvHD. Apart from the main benefit of saving kids' lives, the reason that aGvHD is important to Meso is that it is proof of concept that FDA will approve an off-the-shelf stem cell product and it should generate enough sales to cover cash burn. Acute GvHD in dying children with no alternative treatment was originally thought to provide a quicker pathway to approval - that was a miscalculation. Sad to say, but Meso would've been better off never going near aGvHD and instead accelerating the back pain trials. Then they probably wouldn't have had the potency assay problems they had with Rem-L as Rex-L is a later generation product and it wasn't tainted by Osiris, and back pain is a potentially much higher profit market.

E unfortunately the truth .Maybe the Kids might disagree.

Aloha.