They would be totally stupid if this was not the case. It would be operationally and financially dumb trying to cut costs or make changes to originally planned and agreed trial outlines if full consultation had not taken place with outside interested and expert parties. One of these is obviously the FDA.
Anyways, the following para from the ACADIA ann indicates that the trial optimization has been a collaborative effort.
'ACADIA appreciates the feedback provided by Neuren Pharmaceuticals, investigators from the Phase 2 studies completed by Neuren, Rettsyndrome.org (RSO), and the U.S. Food and Drug Administration (FDA) to further optimize the Phase 3 trial design.'
NEU Price at posting:
$1.25 Sentiment: None Disclosure: Held
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