Following points may lead to a phase 3 clinical trial failure. anyone more knowledgeable please shed more light on these points :
1. Primary outcome analysis used the Unified PD Rating Scale (UPDRS) parts II (activities of daily living) and III (motor examination). Further secondary assessments included Scale for the Assessment of Positive Symptoms (SAPS), Clinical Global Impression Scale-severity (CGI-S), and the Parkinson's Psychosis Rating Scale (PPRS).
2. For the safety analysis, 72.4% and 77.4% of patients, respectively, reported adverse events (AEs), although the 4 serious AEs reported were all considered not related to the study drug. With pimavanserin, the most common AEs were somnolence, oedema, and blood urea increase, while placebo AEs were hallucinations, dizziness, fall, headache, confusion, and hypotension.
Williams noted that based on these data, 39 of these patients have since entered an ongoing open-label, safety extension study. After 48 months in this extension study, pimavanserin remains well tolerated at doses up to 60 mg daily.
JohnMajor44 nobody needs to answer any of your questions because your only here to bash the stock in the first place. Every single message in your view messages is you bashing a stock. It would take about 400 pages to explain to you the SAPS, UPDRS, CGI-S and PPRS ratings scale. Why don't you just go to Wikipedia or god forbid read a book.
The safety analysis you gave 72.4% and 77.4% is actually deemed very exceptable when you consider that you are dealing with people that are suffering from hallucinations and psychosis. The safety of the drug was established before submitting the initial IND and in phase I toxicology testing.
A few AE's are to be expected in every test and the fact that none of them were attributed to Pimavanserin is an extremely good sign. The best indicator from the study is that a high level (39) choose to stay on the drug even after the study concluded. That tells me that the drug is working good for them, they're not having negative side effects, and they feel safe on the medication.
Not to mention the most important point of all which is that the drug is doing exactly what it's designed to do: quickly arrest boughts of psychotic episodes and normalize patients cognitive function. Plus the drug achieves these results two weeks quicker then the Standard of Care meaning two weeks less in the hospital for patients and two weeks less of medical bills. Cost effectiveness gaurantees that it will ALWAYS be chosen over the current SOC.