Ann: Update on BLA for Graft Versus Host Disease, page-235

FDA- more data please

Meso- ok we will take our current stock and stick it in the sickest adult salvage therapy, highest grade aGvHD patients that have 80% plus mortality.

FDA- Ok- terrific- now can you keep supplying the kids while you do the trial because nothing else works.

Meso- Well you see , we need to use the stock allocated for the kids under 12 , in the dying adults now - perhaps you can use Rux or something?

FDA- oh , we haven't thought this through have we??


Meso- not really , no . Here's an idea though - you can give pediatric accelerated approval while we complete the adult trial?


It ain't over folks



Grim news for holders for sure


Si - tell the FDA the EAP ceases when the adult trial begins .
That gives the FDA some grim news of their own


Harsh? Company needs to be viable or no one gets help

Reg