Ok, going to repeat myself
SI said during the conference call that in discussions with FDA following the CRL, FDA made it clear that they wouldn't consider results from a new trial until the potency issues were resolved. There was no way SI could start a new trial until now since it took this long to get past the potency issues. FDA told him they would reconsider based on the new potency data and apparently implied that it, with the other new data supplied, would be sufficient for reconsideration.
So apparently they reconsidered and said: more data please! They gave SI a choice as to whether this additional trial data would be in children or adults. We always planned on the next trial being in aduts so.... that's what is next
Ann: Update on BLA for Graft Versus Host Disease, page-273
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