Just a quick correction in your post above.
SI never said that He is still hoping for accelerated approval in 45-day meeting for children under 12.
He said that he is hoping for children approval while the trial is being held.
FDA turning their own decision(which they took 6 months for) within 45 days is way less likely.
earliest possible approval for padeatric is the first milestone of positive results from the adult study and that shortest milestone would be at least 90 days i.e. somewhere Q1/Q2 next year.
Rest all is good, thanks for posting.
We HAVE TO filter out even small things that may mislead us. got burnt enough already.
Just a quick correction in your post above. SI never said that...
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