Review by Harlan Krumholz – 12/20/2015 – 4:09pm

Data Request Number: 2015-0676 Please use this space to provide any comments, feedback or concerns (optional):

Honestly I am not sure they can answer the question well – and why just look at early vs late relapse – what about the people who do not relapse? And not sure how they will disentangle treatment failure from progression of disease. But I am OK with approving.
The concern is that I am not sure they can really answer these questions:
1. Can the very high rates of relapse shortly after antipsychotic treatment discontinuation be explained on the basis of phenomena such as SSP related to the process of drug withdrawal itself, rather than recurrence of the underlying illness?
2. And if so, can the condition be distinguished from illness recurrence on the basis of symptomatology?

Recommendation for this data request: Approve