2024 Here we go again., page-458

What delaying the start does do, is allow changes in trial design that may otherwise ( cause an expected CRL and then result in a 3rd trial being needed, regardless of the result of primary end point being hit or not as we have already experienced twice)

For example , if the result of the pediatric trial ends up being, we need to run the trial ensuring all 9 donor banks are used.... or maybe only 1 single donor bank is used, this is something MSB could easily facilitate, but not after the trial has began.

I am all for not wasting time and money here.

I suspect, the details of the adult trial design may be included in the BLA resubmission - as MSB have said numerous times in the past two years, FDA want another trial and MSB will perform one after approval, which lends itself to a conditional approval, but also lends itself that if FDA doesn't agree with an aspect of the adult trial, the cat will be put of the bag so to speak for MSB much earlier than usual.