yea maybe..maybe not....end of the day the FDA has the final say regardless..as for trial requirements the type A meeting has to be had. Therefore noone knows how long the timeline is going to be, nor review periods, nor how many people have to be enrolled...so may aswell leave the feelings in the box. Hopefully they get 3rd time lucky
Ann: Update on BLA for Graft Versus Host Disease, page-307
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