Open Label Interim Results next week - from Investvillage MB
The FDA has been very conservative in advancing anti-psychotic drugs in the past. So it caught me by surprise that they told ACAD they no longer needed a 2nd P3 Pima trial. Especially when you consider the Pima trial only lasted 6 weeks and the number of patients was just 200. But before doing that the FDA would have taken a close look at Pima's open-label data. The FDA's decision to not seek a 2nd P3 tells me that the open label trial must have been very safe and probably offers some data to back up the efficacy seen in Pima's P3. ACAD is presenting the open label data next week. Based on the FDA's action I believe the interim data will look very good.
Long term pimavanserin treatment for Parkinson’s disease psychosis (PDP) - An interim analysis of safety and tolerability R. Mills, H. Williams, D. Bahr, K. Chi-Burris, C. Ballard (San Diego, CA, USA)
The P3 trial is also being reported at this meeting along with a sleep data abstract.
Antipsychotic efficacy and motor tolerability in a phase III placebo-controlled study of pimavanserin in patients with Parkinson’s disease psychosis (ACP-103-020)
J. Cummings, S. Isaacson, R. Mills, H. Williams, K. Chi-Burris, D. Bahr, R. Dhall, C. Ballard (Boca Raton, FL, USA)
Improved nighttime sleep and increased daytime wakefulness in patients with Parkinson’s disease psychosis treated with pimavanserin, a selective 5-HT2A antagonist
R. Mills, D. Bahr, K. Chi-Burris, H. Williams (San Diego, CA, USA)
Would be nice but I think they would need some significant new developments, or Baker Brothers goes on another buying spree. The later isnt necessarily a good thing because pps tends to correct afterwords. Also dont forget the market is shaky. Not trying to be negative, just saying.