I believe the gist of it is: FDA is willing to accept new potency data generated to pave the way for FDA to consider pH 3 trial MAB-GVHD001 gor paediatrics as adequate study. I think (a) a few months is quite a good time frame for a potentially significant outcome.
Re adults, a 12 month controlled single arm is also quite a reasonable outcome and given the data and evidence already, that should be a matter of ticking the box ... something FDA likes.
So, much better than we could have potentially ntcipated.
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