In reality, the changes are close to insignificant.
On paper they are a statistical improvement, small as it is.
The half-second secondary endpoints are debatable in my mind and don't have much integrity, but they are quoted statistics, so they are in ink, which gives them weight.
I think it has to be determined if this near-ineffective treatment if given, will lock out any other treatments.
If I was a parent this would be a concern to me, therefore it should be a concern to the FDA also.
ATL-1102 can still be applied regardless, but there can be other treatments that may be locked out.
I think the FDA would not approve it if it was first exposure, but considering the FDA has been condoning Sarepta treatments I think there is a chance the Regulatory ego may push it through.
Time will tell.
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