MSB to dispute FDA finding in Type A meeting, page-98

I'm not too sure on the formalities, but did the FDA has the capacity (legal, processes, mandate) of offering a conditional approval without going through the CRL or do they need to be asked via the CRL?

I had this question too. I'm assuming that isn't their practice, because that would need to include details about what such a condition would loook like (we approve it subject to a further trial etc). But how could they say what such a further trial would need to look like without discussions with the company first. Hence the CRL and the Type A to thrash it out.

My interpretation (or hope) is that the FDA wants a committment to a confirmatory trial as a condition for accelerated approval (they'll accept adults - but put children in the letter because it would be odd not to given the application is for pediatric), and they are letting MSB know via the CRL on the assumption they'll come back and present their plans for the adult trial.