Thx for that link .
So this is March 2023 and they now look like they are about 1 yr behind the schedule they laid out here ...expecting FDA approval in H1 2025 and commercial launch in H2 2025 .
They started the adult trial in 2023 and its taken them to May 2025 to get the first 100 enrolled.
Their patents expire in 2032 and they hope to get a Hatch Waxman 5 yr extension .
So my take ...with the Pediatric approval and this new capital raise ...its a full on press to get the adult trial fully enrolled by EOY .
So updates on clinical sites adding patients will be key .
Interim review ...my guess this will be out last half of Sept ...is also key .
In the slim chance the adult trial is stopped for efficacy ...huge home run .
If the review board suggests they only need 160 enrolled for stat sig data ( P .01 or better preferred )...another win .
If review board says add more patients ...huge negative .
If you have any info , besides what reported on clinical trials .org for recruitment , more sites activated , please share
thx
Kiwi
PS. Dr Chung has mentioned several times ( over the videos I've watched ) ...how conserve he was in designing the adult trial . He may be wondering now if he was to conservative ...JMO
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