The FDA initially requested further data in the form of another RCT - requesting high quality in vivo clinical data.
After the last CRL, MSB specifically said the fda requested further data, and they would supply that data in the form of another adult trial - clinical data.
Now, MSB has gone back to the bench top and gathered some sort of in vitro data (low quality evidence), which we have no information about, and everyone seems to think this is going to be the silver bullet.
It just doesn't make any sense to me - it's blindingly obvious they're planning on doing the adult trial prior to approval - your quote you posted even says they're planning on validating the potency data with the adult trial.
The FDA will require the adult trial before approval - in my opinion, all the signs, all the releases by MSB, everything the FDA has requested in the past point to this fact.
As always.... happy to be wrong. But I would be very surprised
(20min delay)