MSB Trading 2021 - paradigm shift, page-783

Imagine the judge asking the FDA:
1. So you've discussed with msb on path to approval & ticked off the trial design
2. You then gave Ryoncil orphan designated indication and fast track too
3. You then had a rolling review, accepted the BLA, and gave it priority review
4. You then set up an ODAC committee, for independence and asked them to vote
5. You then discarded the ODAC 9-1 vote, citing the need for RCT and better understanding of MOA
6. Experts tell you that RCT is not feasible for kids
7. You've approved a drug for the same indication, with serious side effect on single arm trial. Isn't that precedent?
8. Recent studies has demonstrated MOA

So let me ask you? How do you reject the application for accelerated approval? On what ground?
...
Now is that the legal battle that the FDA wants to have or settle internally via their own dispute process?

Bring it on!!!