Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-355

I think you are wrong on two fronts.

Firstly, "that approval will likely require the adult trial" - that's not true. So you are wrong here!
Plan A is to discuss the new potency assay data with the FDA this month and that may be sufficient for the Ryoncil BLA Resubmission - i.e. possible approval of Ryoncil for Pediatric without being contingent on the adult trial.
If plan A is successful, then the adult trial has no impact on the approval of Ryoncil for Pediatric.


Secondly, if Plan A fails - then Plan B is activated.
With plan B, there is a need to get the adult trial started, yes started and not completed (as you constantly & wrongly repeat), to get an AA for Ryoncil for Pediatric.
This will require a surrogate end-point - what that is will need to be clarified by the FDA. This surrogate end-point does not need to wait for the adult trial to be completed. AA for Ryoncil for Pediatric will only be requested if and only if, plan A fails.