And for those that are going to say I'm full of bull and just being negative - these are simply the cold hard facts.
When recruiting for the phase three trial, including both children and adults, only looking at steroid refractory (not steroid and Rux) aGVHD, it took them three years to recruit sufficient numbers.
This is not including study design and approval, which I hope is currently happening (though we have been kept int the dark).
Maybe MSB will run a smaller trial. And it sounds like MSB isn't willing to do a placebo controlled trial. So that will likely aid recruitment times a bit - but it will be a significantly less powered trial and it may be more difficult to achieve significance.
And after all this, what if the trial doesn't succeed? Because the first one didn't - it was only, you guessed it, post hoc subgroup analysis that found significance (a very concerning trend).
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