I've calmed down now.
You are, of course, correct- label extension would occur with a confirmatory trial in adults.
It appears we no longer have the financial pressures of completing an adult trial before needing to raise funds again.
Pediatric approval and subsequent income stream will rid us of the shorters.
The FDA has seen whatever light Si was shining and reversed their course.
No longer requiring the adult trial ,imo, is tantamount to saying the 001 pediatric trial was adequate and well controlled.
If potency was our last hurdle, then August 2024 maybe one of my favourite months ever.
GLTALTH
Reg
I've calmed down now. You are, of course, correct- label...
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