Question · Q1 2024
Colin Bristow inquired about the timeline, cost, and specific FDA requirements for the 12-month safety data for the TRANQUILITY program in Alzheimer's agitation.
Answer
Executive Vincent O'Neill stated that while specific dates could not be provided, the timeline and cost for the TRANQUILITY In-Care study are expected to be very similar to the previous TRANQUILITY II trial. He confirmed that the 12-month safety data is a clear requirement and will be part of the sNDA package.
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