Bologny. Leerink note available on twitter - see tweet by @geraldfu at 10:57pm eastern time Mon. July 15. Really same rehash of "this is impressive but our network of experts wonders if a phase 3 will be needed before approval."
Could the following scenario unfold?
AA granted but only for child still ambulatory and whose age is greater than seven, maybe eight.
Child on phase II automatically included in confirmatory study to check long-run efficacy and safety of drug.
Phase III study needed for non ambulatory and less than seven years child.