If you go back an look at the Phase 3 data, they only have a slightly higher level of deaths in the treatment group over the placebo group. The FDA opted to handle it with a Black Box warning. This sudden "to do" about the deaths is like the most captain obvious statement of the year. I think it states more about shareholder inability to do proper due diligence then anything. We already know about the elevated risk of death in elderly patients. Its right on the label. The issue with the early trials not working were about being poorly designed by the old management. Once they designed a proper trail for PDP, they did get very good results. None of this isn't information shareholders hasn't heard a dozen times since Nuplazid went commercial.
Increased risk of death in elderly patients with dementia-related psychosis. Medicines like NUPLAZID can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.