I think everyone is misreading the announcement. MSB did not say they are dropping the adult trial.
Plan A (original plan) was always to get approval in pediatrics, then do an adult trial to use the results for seeking label extension to adults.
Plan B was, if the FDA still didn't like our assays, we would do adult trial to use in seeking approval for both children and adults.
Now we are back to plan A. I can see that might delay the adult trial, as MSB would be focused on the resubmission and also might want to wait for possible curveballs on the pediatric BLA before commencing the adult trial.
But I believe it is wishful thinking to expect label extension to adults without another trial. I think at best they might give an AA for adults but require the new trial before awarding full approval for adults.
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