Clearly,
A three month trial is less expensive than a six month trial.
And it might be expected that the greatest effect will be seen in younger patients.
So I see this as Acadia simply trying to achieve the best result at least cost. And perhaps moving to market more quickly.
Remember,
Participants will be receiving high doses, adjusted for weight. And, although the trial is double-blinded, if none of the patients are showing significant signs of improvement after three months, it's doubtful a longer trial would then show a sudden improvement. It would be a waste of money.
However,
If there is a noticeable improvement among some participants by the three month mark, then the trail could be extended out to six months, perhaps with all participants moving to trofinetide.
So,
I don't see the three month trial as a problem, and I like the focus on younger patients.
GLTAH
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